FDA.reportPublic FDA data

STRYKER ENDOSCOPY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29364852936485STRYKER ENDOSCOPY1N2026-01-015900 Optical Ct SAN JOSE CA US 95138
30121039783012103978Stryker Endoscopy1N2026-01-015670 Greenwood Plaza Blvd Suite 125 Greenwood Village CO US 80111

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
37751773938184K993166STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEMHWC2000-08-04
37751526317417K993045BARIATRIC LAPAROSCOPE, MODEL 367GCJ1999-10-27
37751839960379K991960SERFAS, SERFAS GENERATOR, SERFAS CONSOLE, SERFAS PROBE, SERFAS HANDPIECE CABLE, SERFAS FOOTSWITCHGEI1999-08-13
37752028239843K991563CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, CHIH1999-10-13
37751622849409K9835663-CHIP VIDEO CAMERAGCJ1999-01-11
37751451159892K983557STRYKER WEDGE SUTURE ANCHORMBI1998-12-18
37751297971422K983220STRYKER INFRAVISION ESOPHAGEAL KITFAT1999-06-04
37752024569217K982375STRYKER HIP ARTHOROSCOPY SETHRX1998-10-02
37751850887880K981464OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODEKNF1998-07-10
37751565733190K973259K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)OCZ1997-09-10
37751638151489K972233STRYKER WEDGE INTERFERENCE SCREW SYSTEMHWC1997-08-05
37751450251910K965175HOWMEDICA MAINSTAY ANCHORJDR1997-03-13
37751309311741K965093OMNITECH RESECTOSCOPE ROLLER ELECTRODEFAS1997-03-19
37751769359762K964365RESECTOSCOPE CUTTING LOOP ELECTRODEFAS1997-04-22
37751286747588K963765STRYKER STRYKEFLOW ELECTROCAUTERY PROBESGEI1997-01-31
37751126442724K963646STRYKER STRYKEFLOW SUCTION IRRIGATOR GRAVITY FLOWGEI1997-04-16
37751869749412K963304STRYKER TEMPEST ORTHOPEDIC PUMPHRX1997-01-22
37751804237555K962075HSW GMBH ARTHROSCOPEHRX1997-01-17
37751517413515K961971Q-5000FSS1996-06-28
37751066859084K960738STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H)KCT1997-05-06
37751219062231K954726STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)GCX1995-11-29
37751080874024K952681STRYKER HUMMER II MICRODEBRIDER SYSTEMERL1995-07-20
37751187390258K952460STRYKER ACL INTERFERENCE SCREW SYSTEMHWC1995-09-28
37751113546395K951267STRYKER UNIVERSAL ACL INSTRUMENTATION SYSTEMHRX1995-09-01
37751634381668K945088GABRIEL URETERAL ILLUMINATOR SYSTEM IIFCS1995-02-07
37751214261378K944593STRYKER PRESSURE SENSING CANNULAHRX1995-09-01
37751172904799K944210ARTHROSCOPE ACCESSORIESHRX1995-02-14
37751478762549K944186SINUSCOPEEOB1994-11-07
37751124621380K944025SURGICAL INSTRUMENT TRAYFSM1994-11-22
37751376988890K943508INSUFFLATOR TUBING WITH FILTERHET1994-11-17
37751487387748K943100STRYKER OPERATING LAPAROSCOPEHET1995-08-10
37751420406500K942194QUANTUM BI-POLAR ELECTROSURGICAL CABLEGEI1994-05-23
37751394534116K941541HSV LAPAROSCOPY SETGCJ1994-05-16
37751461249217K941333SE5 ARTHROSCOPY SYTEMHRX1994-11-10
37751736159187K935237STRYKER ENDOSCOPIC INSTRUMENTS AND ACCESSORIESGEI1994-03-21
37751987545467K935234STRYKER ENDOSCOPIC VIDEO ACCESSORIESGCJ1994-03-18
37752073293300K935222STRYKER ENDOSCOPIC ELECTROSURGICAL INSTRUMENTS & ACCESORIESGEI1994-03-25
37751266356937K935221STRYKER ARTHROSCOPIC MANUAL SURGICAL INSTRUMENTSHRX1994-04-28
37751967752333K934094STRYKER LAPAROSCOPIC SUCTION IRRIGATORGCJ1994-02-18
37751830890352K933520ENDOSCOPIC ANTI-FOG KIT, 100-302-00GCJ1993-08-24
37751299391249K910858STRYKER ARTHROSCOPIC INFUSION PUMPHRX1991-05-23
37751610195813K910132STRYKER LAPAROSCOPEGCJ1991-02-21
37751145069501K901153SONY VO-5800H VIDEOCASSETTE RECORDERJAA1990-04-19
37751109437715K822286AUTOCUFF (PHOTOS ENCLOSED WITH 510KKZD1982-08-27
37751084501593K820624SYN-OPTICS #5200FET1982-04-01
37751043166307K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemIZI2026-05-28
37751867207918K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging ModalityGCJ2026-02-18
37751276905673K260108L12 LED Light Source with AIMOWN2026-02-12
37751689418945K254014Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice ControlGCJ2026-01-13
37751948057694K253888MOLLI 2 SystemNEU2025-12-31
37751580727641K253602Precision S 4K SinuscopeGWG2026-06-04
37751848562065K252012SPY Cystoscope/HysteroscopeHIH2025-07-18
37751855530672K250544Knotilus+ Biocomposite Knotless AnchorMAI2025-05-23
37751830376603K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorMAI2025-05-21
37751951139963K241401Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice ControlGCJ2024-08-15
37751248573420K2401741688 4K Camera System with Advanced Imaging ModalityGCJ2024-02-22
37751850530713K240042MOLLI 2 SystemNEU2024-09-25
37751893696672K234149MOLLI 2 SystemNEU2024-09-26
37751905305435K233893AlphaVent Knotless SP PEEK AnchorMBI2024-01-25
37751145454128K233635SPY Cystoscope/HysteroscopeHIH2024-02-12
37751494496876K2333271788 4K Camera System with Advanced Imaging ModalityGCJ2024-01-09
37751932490381K232683Knotilus+ PEEK Knotless AnchorMBI2023-10-24
37751556837140K232157Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice ControlGCJ2023-08-18
37751976946624K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMOWN2023-09-20
37751454297191K231579MOLLI 2NEU2023-10-26
37751843207479K231093AlphaVent Suture AnchorsMBI2023-08-30
37751930490745K230886Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice ControlGCJ2023-06-21
37751565281390K230754L12 LED Light Source with AIMOWN2023-04-11
37751987244804K2306051788 4K Camera System with Advanced Imaging ModalityGCJ2023-03-31
37751596977022K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)GCJ2023-02-23
37751209780604K230045HipCheckQIH2023-09-29
37751675925506K223107MOLLI 2NEU2023-01-18
37751554565241K2221301688 4K Camera System with Advanced Imaging ModalityGCJ2022-08-19
37751510674722K222079Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice ControlGCJ2022-10-11
37751292118516K221217SPY LaparoscopeGCJ2022-06-17
37751812412709K2208951688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)GCJ2022-04-22
37751147339990K220108SDC4K Information Management System with Device and Voice Control PackageGCJ2022-02-09
37751197086777K2125111688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)GCJ2021-11-04
37751625792435K212055Connected OR Hub with Device and Voice ControlGCJ2021-12-16
37751309099957K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K SinuscopesGWG2021-08-06
37751339379302K210628X-FLO Fluid Management SystemHIG2021-11-04
37751943090352K210584SDC3 HD Information Management System with Wireless Device Control CapabilityGCJ2021-03-18
37751395036384K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM LaparoscopesGCJ2021-04-13
37751868079419K210078Stryker ProCinch Adjustable Loop DeviceMBI2021-03-11
37751263205188K202659Stryker ArthroscopeHRX2020-12-01
37751163886570K202592Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality)GCJ2020-10-08
37751488085992K202355Stryker Omega PEEK Knotless Anchor SystemMBI2020-11-13
37752018473514K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareOWN2020-11-05
37751519195162K201434Connected OR Hub with Voice Control, Connected OR Hub with Device ControlGCJ2020-07-28
37751322163314K201361PNEUMOCLEARHIF2020-07-29
37751602754692K200737SPY Portable Handheld Imaging (SPY-PHI) SystemOWN2020-05-21
37752036757829K2003101688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging ModalityGCJ2020-03-06
37752020112887K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableOWN2019-11-19
37751921207336K192172Connected OR Hub with Device and Voice ControlGCJ2019-09-09
37751370428921K191259Stryker CrossFlow Integrated Arthroscopy PumpHRX2019-07-12
37751415553710K191102Precision S 4K SinuscopeEOB2019-09-06
37751501649759K191046L10 LED Light Source with AIM, L11 LED Light Source with AIMOWN2019-05-10
37751722338774K190729SPY Portable Handheld Imaging (SPY-PHI) SystemOWN2019-04-19
37751582053038K183470Precision Ideal Eyes ArthroscopesHRX2019-01-07
37751945559014K182606PINPOINT Endoscopic Fluorescence Imaging SystemGCJ2018-11-21
37751149794662K182359HipCheckLLZ2018-12-13
37751815523914K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIMGCJ2018-11-05
37751469363366K181258ConnectedOR Hub with Device and Voice ControlGCJ2018-11-05
37751981780678K181083Stryker All-PEEK Knotless Anchor SystemMBI2018-07-23
37751249036914K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorMBI2018-04-04
1887621266127801K172921Stryker Self-Punching ICONIXMBI2017-11-20
37751085818389K172048FluidSmartHIG2017-09-05
37751386468920K171947SOLOASSIST IINAY2018-09-21
1887621380719768K171465Stryker Self-Punching ICONIXMBI2017-08-24
37751109803276K171391Stryker 90-S Max SERFAS Energy ProbeGEI2018-01-26
37751536299428K170784PNEUMOCLEARHIF2017-05-15
37751132996786K170364Collagen Meniscus Implant XLOLC2017-05-02
1887621533940802K170098ICONIX TT All Suture AnchorMBI2017-03-31
1887621792244383K162310XBraid TT Suture TapeGAT2016-11-10
37751710442094K160332Stryker SDC3 HD Information Management System with Wireless Device Control CapabilityGCJ2016-05-18
37751424467590K160050SERFAS 90-S Electrosurgical ProbeGEI2016-05-03
37751043820888K153087IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse CurvedGAT2016-07-14
37751384672237K152951Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization TrayKCT2015-12-28
37751377380056K151932Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use TubingHRX2016-03-31
37751365259774K151314CinchLock Flex Knotless Suture AnchorMBI2015-07-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GCJ432026-02-18
MBI212024-01-25
HRX172020-12-01
GEI132018-01-26
OWN92026-02-12
HWC92007-09-17
HIF62020-07-29
NEU52025-12-31
HIH52025-07-18
MAI42025-05-23
HIG32021-11-04
LLZ32018-12-13
GAT32016-11-10
KCT32015-12-28
FCS32015-08-20
FGB32012-09-12
HET32008-12-16
GWG22026-06-04
EOB22019-09-06
OLC22017-05-02
HTY22015-04-17
FAJ22007-12-18
OCW22007-04-05
GCX22004-12-09
JDW22002-03-15
FAS21997-04-22
SIT12026-07-17
IZI12026-05-28
QIH12023-09-29
QPQ12021-07-12
NAY12018-09-21
FST12009-04-22
FCW12008-12-19
MMP12004-11-30
LJH12004-10-25
KNS12004-08-09
FLN12002-08-06
FAT11999-06-04
KNF11998-07-10
OCZ11997-09-10

PMN#

93 records. Showing 81-93. Previous