FDA.reportPublic FDA data

ETHICON ENDO-SURGERY, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30050758533005075853ETHICON ENDO-SURGERY, LLC1Y2026-01-01475 CALLE C GUAYNABO PR US 00969

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10705036003113HARMONIC - Harmonic Torque Lock Blade Wrench+1(877)384-4266customersupport@eesus.jnj.com
10705036046523Megadyne - MEGADYNE Energy Signal Cable+1(877)384-4266customersupport@eesus.jnj.com
20705036003271HARMONIC - Harmonic Blue Test Tip for use with Blue Hand Piece Only+1(877)384-4266customersupport@eesus.jnj.com
20705036013904N/A - Cart G11+1(877)384-4266customersupport@eesus.jnj.com
20705036038396DUALTO Energy System - Energy Double Footswitch+1(877)384-4266customersupport@eesus.jnj.com
20705036038402DUALTO Energy System - Energy Single Footswitch+1(877)384-4266customersupport@eesus.jnj.com
20705036038419DUALTO Energy System - Energy Round Footswitch+1(877)384-4266customersupport@eesus.jnj.com
20705036038426DUALTO Energy System - DUALTO Energy Cart+1(877)384-4266customersupport@eesus.jnj.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
238891055732762K990362INSTRUMENT, ULTRASONIC, SCALPELGEI1999-09-17
238891170899254K984240ENDOPATH ENDOSCOPIC INSTRUMENTSGEI1999-06-22
238891986348816K983925ENDOPATH ULTRA VERESS NEEDLEHIF1999-02-03
238891191399048K983536PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERSGDW1998-12-18
238891871324409K972679ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)GCJ1997-09-19
238891201576253K972578ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVEGCJ1997-10-01
238891176965945K963760NON-SHIELDED SURGICAL TROCAR AND SLEEVEGCJ1997-01-08
238891431464209K962584ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADELFL1996-11-04
238891490926303K940967MODIFIED ENDOPATH ILSOCW1994-05-27
238891810203059K931111ENDOPATH DISPOSABLE FLEXIBLE SURGICAL CANNULAGCJ1993-06-22
238891948160445K920110ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVEGEA1992-04-02
238891297396525K910875ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLEFDP1991-03-19
238891768069321K904993LAPAROSCOPIC ELECTROSURGICAL DEVICEGEI1991-01-25
238891800298487K864102LIGACLIP 20/20* MULTIPLE CLIP APPLIERFZP1986-11-05
238891762274534K830503LIGACLIP TITANIUM LIGATING CLIPFZP1983-03-08
238891556745318K820837DISPOSABLE MULTIPLE LIGATING CLIPGDO1982-05-28
238891244294999K260196ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm)GDW2026-05-11
238892037442439K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)OXC2026-01-09
238891069457388K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T)GDW2025-12-17
238891742636466K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)GDW2025-05-14
238891382780092K243067The ETHICON™ Total Energy SystemGEI2025-01-17
238891168364972K241630ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)GDW2024-10-28
238891692540863K241629ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)GAG2024-07-03
238892016507676K232313LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)FZP2023-08-29
238891042578548K230387ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S)GEI2023-04-13
238891646271153K223760ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G)GDW2023-03-15
238891278332516K221790HARMONIC 700 ShearsLFL2023-02-28
238891411645605K221343ECHELON ENDOPATH Staple Line ReinforcementOXC2022-09-16
238891237951055K213633ECHELON 3000 45mm Stapler, ECHELON 3000 60mm StaplerGAG2022-04-08
238891343939004K211273Harmonic Hand Piece, Blue, Harmonic Hand Piece, GrayLFL2021-05-21
238891878891573K202665Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mmGDW2020-10-15
238891634936784K201696ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft LengthGEI2021-01-22
238891066196541K201280Ethicon Circular Stapler, Ethicon Circular Stapler -XL SealedGDW2020-07-27
238891402469912K201066ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft LengthGEI2021-01-22
238891002310831K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11GEI2020-05-11
238891172200158K200420Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, GreenGDW2020-06-29
238891359001579K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF SensorFYD2020-06-26
238891901539198K191555HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm lengthLFL2020-02-28
238891283665341K190937Echelon Endopath Staple Line ReinforcementOXC2019-10-14
238891797021174K183435Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and BlackGDW2019-02-06
238891404008434K181653Ethicon Circular Stapler, Ethicon Circular Stapler -XL SealedGDW2018-09-18
238891237776901K181488LIGACLIP 12mm L Endoscopic Rotating Multiple Clip ApplierFZP2018-10-30
238891809454681K180403ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft LengthGEI2018-05-23
238891711868178K180031Endopath Electrosurgery Probe Plus IIGEI2018-05-07
238891837955327K172580ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft LengthGEI2017-11-20
238891830653355K163548ENSEAL X1 Large Jaw Tissue SealerGEI2017-02-14
238891622451915K163523ECHELON CIRCULAR Powered StaplerGDW2017-04-18
238891504026932K163454ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mmGDW2017-01-05
238891180231896K160554Enseal X1 Large Jaw Tissue SealerGEI2016-09-09
238891729362548K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mmGDW2016-03-22
238891096056279K160128Endopath Electrosurgery Probe Plus IIGEI2016-04-28
238891229773202K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyLFL2015-07-10
238891073026191K150840Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip ApplierFZP2015-09-10
238891490111277K150026Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear StaplerGDW2015-05-18
238892065464751K141952ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCEDGDW2014-11-24
238891749390710K141122HARMONIC SCALLOP BLADE, GENERATOR G11GEI2014-09-15
238891454208979K140560ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATINGGDW2014-04-22
238891926384862K133314HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGYLFL2013-12-03
238891292000052K132612HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCELFL2013-10-17
238891518169330K132522HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLELFL2013-12-16
238891743903163K132512HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLELFL2013-10-24
238891671976228K131435ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW,GEI2013-10-03
238891524662319K130653ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUGDW2013-03-29
238891195062005K122797ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAWGEI2013-01-25
238891294866836K122511ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATHGCJ2012-10-01
238891236926547K121600ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITEGDW2012-07-16
238891492558959K121550HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGYLFL2012-08-22
238891744589321K110699LIGAMAX 5FZP2011-03-25
238891275735932K101520ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RHGEI2010-12-10
238892042281664K100597HARMONIC FOCUS SHEARSLFL2010-04-07
238891818073007K092577ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75)GDW2009-09-15
238892059688693K091322CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40GGDW2009-06-01
238891663663210K081146ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)GDW2008-06-26
238891642672595K080839ECHELON GRAY CARTRIDGE, MODEL ERC45MGDW2008-05-21
238892054518027K072203HARMONIC 10CM COMBINATION HOOK BLADELFL2007-09-25
238891759878981K070887ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)GDW2007-05-25
238891653193470K070198ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02GCJ2007-06-13
238892000281394K063192HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIPLFL2007-01-30
238891692875406K062209BASX BLADELESS TROCARGCJ2006-10-10
238892003797211K062000HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCHLFL2006-09-25
238891737735098K060245HARMONIC SCALPEL BLADES AND SHEARSLFL2006-04-07
238891107475302K053631CONTOUR TRANSTAR CURVED CUTTER STAPLER SETGDW2006-01-30
238891670124200K051301PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIESGDW2005-08-30
238891444627206K032676ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCARGCJ2003-10-30
238892062845103K030925PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01GDW2003-05-15
238891021145120K020779PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERSGDW2002-06-05
238891985063881K012176ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145LFL2001-10-01
238891466663695K011501ENDOPOUCH RETRIEVERGCJ2001-07-19
238891888734376K002906ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07LFL2000-12-15
238891133928962
238891215397111
238891023474612
238891088224448
238891153707755
238891222307312
238891335335091
238891878663634

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GDW282026-05-11
GEI182025-01-17
LFL172023-02-28
GCJ92012-10-01
FZP62023-08-29
OXC32026-01-09
GAG22024-07-03
FYD12020-06-26
HIF11999-02-03
OCW11994-05-27
GEA11992-04-02
FDP11991-03-19
GDO11982-05-28

PMN#

61 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next