FDA.reportPublic FDA data

Roberta Franca

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
97106493003565435Roberta Franca1N2026-01-014545 Creek Rd Blue Ash OH US 45242

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
148991102393790K990362INSTRUMENT, ULTRASONIC, SCALPELGEI1999-09-17
148991554236862K984240ENDOPATH ENDOSCOPIC INSTRUMENTSGEI1999-06-22
148991520060452K983925ENDOPATH ULTRA VERESS NEEDLEHIF1999-02-03
148991834736525K983536PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERSGDW1998-12-18
148991148078054K972679ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)GCJ1997-09-19
148991177778175K972578ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVEGCJ1997-10-01
148991263419641K963760NON-SHIELDED SURGICAL TROCAR AND SLEEVEGCJ1997-01-08
148992012537832K962584ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADELFL1996-11-04
148991056942553K940967MODIFIED ENDOPATH ILSOCW1994-05-27
148991804547821K931111ENDOPATH DISPOSABLE FLEXIBLE SURGICAL CANNULAGCJ1993-06-22
148992055998482K920110ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVEGEA1992-04-02
148991891469713K910875ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLEFDP1991-03-19
148991246931249K904993LAPAROSCOPIC ELECTROSURGICAL DEVICEGEI1991-01-25
148991456331851K820837DISPOSABLE MULTIPLE LIGATING CLIPGDO1982-05-28
148991150740602K191555HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm lengthLFL2020-02-28
148991207261120K181653Ethicon Circular Stapler, Ethicon Circular Stapler -XL SealedGDW2018-09-18
148991012816120K181488LIGACLIP 12mm L Endoscopic Rotating Multiple Clip ApplierFZP2018-10-30
148991874589446K180403ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft LengthGEI2018-05-23
148991084813688K180031Endopath Electrosurgery Probe Plus IIGEI2018-05-07
148991506400404K172580ENSEAL 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
148991733447066K163548ENSEAL X1 Large Jaw Tissue SealerGEI2017-02-14
148991489360536K163523ECHELON CIRCULAR Powered StaplerGDW2017-04-18
148991057205930K163454ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mmGDW2017-01-05
148991353201700K160554Enseal X1 Large Jaw Tissue SealerGEI2016-09-09
148991825366798K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mmGDW2016-03-22
148991836218688K160128Endopath Electrosurgery Probe Plus IIGEI2016-04-28
148991840233539K151340HARMONIC Focus Long Shears + Adaptive Tissue TechnologyLFL2015-07-10
148991893725996K150840Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip ApplierFZP2015-09-10
148991669993269K141952ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCEDGDW2014-11-24
148991149731173K140560ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATINGGDW2014-04-22
148991378038477K133314HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGYLFL2013-12-03
148991881106864K132612HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCELFL2013-10-17
148991856606702K132522HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLELFL2013-12-16
148991629075951K132512HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLELFL2013-10-24
148991009574354K131435ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW,GEI2013-10-03
148991883368677K130653ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUGDW2013-03-29
148991971168590K122797ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAWGEI2013-01-25
148991459629998K122511ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATHGCJ2012-10-01
148991603005482K121550HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGYLFL2012-08-22
148991552086050K110699LIGAMAX 5FZP2011-03-25
148991843966952K101520ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RHGEI2010-12-10
148991175005371K100597HARMONIC FOCUS SHEARSLFL2010-04-07
148991764159890K091322CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40GGDW2009-06-01
148991345545681K081146ECHELON ENDOSCOPIC LINEAR CUTTERS (ARTICULATING AND STRAIGHT)GDW2008-06-26
148991560210421K072203HARMONIC 10CM COMBINATION HOOK BLADELFL2007-09-25
148992059048931K070887ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)GDW2007-05-25
148991254666603K070198ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02GCJ2007-06-13
148991714286860K063192HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIPLFL2007-01-30
148991204059092K062209BASX BLADELESS TROCARGCJ2006-10-10
148991212080525K062000HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCHLFL2006-09-25
148991353922365K060245HARMONIC SCALPEL BLADES AND SHEARSLFL2006-04-07
148991561105002K053631CONTOUR TRANSTAR CURVED CUTTER STAPLER SETGDW2006-01-30
148992012701187K051301PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIESGDW2005-08-30
148991899418962K032676ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCARGCJ2003-10-30
148991932016996K030925PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01GDW2003-05-15
148991222858972K020779PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERSGDW2002-06-05
148991113082883K012176ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145LFL2001-10-01
148991987496846K011501ENDOPOUCH RETRIEVERGCJ2001-07-19
148992004283455K002906ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07LFL2000-12-15
148991132396946
148991006958798
148991009574354
148991012816120
148991031413047
148991045791338
148991056942553
148991057205930
148991083069156
148991084813688
148991102393790
148991148078054
148991149731173
148991150740602
148991177778175
148991204059092
148991222858972
148991238949113
148991254666603
148991263419641
148991341887954
148991345545681
148991353201700
148991353922365
148991378038477
148991456331851
148991459629998
148991489360536
148991494344859
148991506400404
148991552086050
148991554236862
148991597279863
148991603005482
148991648414371
148991669993269
148991703640869
148991714286860
148991732621586
148991733447066
148991738133939
148991746118336
148991764159890
148991804547821
148991836218688
148991840233539
148991845987259
148991856606702
148991868512296
148991874589446
148991881106864
148991883368677
148991899418962
148991908938288
148991971168590
148991987496846
148992004283455
148992004952348
148992012537832

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LFL152020-02-28
GDW152018-09-18
GEI122018-05-23
GCJ92012-10-01
FZP32018-10-30
HIF11999-02-03
OCW11994-05-27
GEA11992-04-02
FDP11991-03-19
GDO11982-05-28