# Stryker Endoscopy

- Location (FDA's records): San Jose, CA
- FDA decisions: 103 (1993–2026): 102 510(k) clearances and 1 De Novo grant
- Product codes: GCJ (25), HRX (11), MBI (11), GEI (8), HWC (7), MAI (4), FGB (3), GCX (3), JDW (3), HET (3), HIH (3), ERL (3)
- 510(k) review time since 2016: median 56 days, against 99 for FDA's reviews in the same codes and years (17 of 24 faster)
- Predicates its devices cite: 125 (40 its own); citations of its devices by later devices: 131 (40 its own)
- Recalls linked to its devices: 75 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Arthrex, Inc.: 20 (https://510kreport.com/company/arthrex)
- Stryker Corp.: 19 (https://510kreport.com/company/stryker)
- Arthrocare Corp.: 9 (https://510kreport.com/company/arthrocare)
- Karl Storz Endoscopy: 3 (https://510kreport.com/company/karl-storz-endoscopy)
- Computer Motion, Inc.: 3 (https://510kreport.com/company/computer-motion)
- Linvatec Corp.: 2 (https://510kreport.com/company/linvatec)
- Gabriel Medical, Inc.: 2 (https://510kreport.com/company/gabriel-medical)
- Stryker Instruments: 2 (https://510kreport.com/company/stryker-instruments)

## Firms that cite its devices most
- Stryker Corp.: 17 (https://510kreport.com/company/stryker)
- Alliance Medical Corp.: 6 (https://510kreport.com/company/alliance-medical)
- Smith & Nephew, Inc.: 2 (https://510kreport.com/company/smith-nephew)
- Genicon, Inc.: 2 (https://510kreport.com/company/genicon)
- Stryker Sustainability Solutions: 2 (https://510kreport.com/company/stryker-sustainability-solutions)
- Stryker Communications Corp.: 2 (https://510kreport.com/company/stryker-communications)
- Henke-Sass, Wolf GmbH: 2 (https://510kreport.com/company/henke-sass-wolf)
- Linvatec Corp.: 2 (https://510kreport.com/company/linvatec)

## Its most-cited devices
- K040390: Stryker Urology and Gynecology Hardware System (2004), cited by 7
- K142310: Stryker Infrared Fluorescence (IRF) Imaging System (2014), cited by 6
- K041810: Serfas Energy System (2004), cited by 5
- K973195: Total Performance System Shaver (1997), cited by 5
- K991960: Serfas, Serfas Generator, Serfas Console, Serfas Probe, Serfas Handpiece Cable, Serfas Footswitch (1999), cited by 5
- K093677: Stryker Arthroscope (2010), cited by 5

## Recent decisions
- K262369: AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down (Jul 30, 2026)
- DEN250040: SportSuite Vision Software (Jul 17, 2026)
- K253602: Precision S 4K Sinuscope (Jun 4, 2026)
- K261037: 780 nm SPY Portable Handheld Imaging (SPY-PHI) System (May 28, 2026)
- K260185: 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality (Feb 18, 2026)
- K260108: L12 LED Light Source with AIM (Feb 12, 2026)
- K254014: Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (Jan 13, 2026)
- K253888: MOLLI 2 System (Dec 31, 2025)

Source page: https://510kreport.com/company/stryker-endoscopy