Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stryker Endoscopy — Predicate Candidate Screening
103 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
198 days90th percentile
103clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-I | Stryker Endoscopy | 2026-07-30 | 20 | 0 |
| DEN250040 | SportSuite Vision Software | Stryker Endoscopy | 2026-07-17 | 318 | 0 |
| K253602 | Precision S 4K Sinuscope | Stryker Endoscopy | 2026-06-04 | 198 | 0 |
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | Stryker Endoscopy | 2026-05-28 | 59 | 0 |
| K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4 | Stryker Endoscopy | 2026-02-18 | 28 | 0 |
| K260108 | L12 LED Light Source with AIM | Stryker Endoscopy | 2026-02-12 | 29 | 0 |
| K254014 | Connected OR Hub with Device and Voice Control; SDC4K Inform | Stryker Endoscopy | 2026-01-13 | 29 | 0 |
| K253888 | MOLLI 2 System | Stryker Endoscopy | 2025-12-31 | 27 | 1 |
| K252010 | SPY Laparoscope | Stryker Endoscopy | 2025-07-24 | 27 | 0 |
| K252012 | SPY Cystoscope/Hysteroscope | Stryker Endoscopy | 2025-07-18 | 21 | 0 |
| K250544 | Knotilus+ Biocomposite Knotless Anchor | Stryker Endoscopy | 2025-05-23 | 87 | 0 |
| K250528 | Stryker AlphaVentâ„¢ Knotless SP Biocomposite Anchor | Stryker Endoscopy | 2025-05-21 | 86 | 0 |
| K241401 | Connected OR Hub with Device and Voice Control; SDC4K Inform | Stryker Endoscopy | 2024-08-15 | 90 | 0 |
| K240407 | ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONI | Stryker Endoscopy | 2024-03-07 | 27 | 0 |
| K240174 | 1688 4K Camera System with Advanced Imaging Modality | Stryker Endoscopy | 2024-02-22 | 30 | 0 |
| K233635 | SPY Cystoscope/Hysteroscope | Stryker Endoscopy | 2024-02-12 | 91 | 0 |
| K233893 | AlphaVent Knotless SP PEEK Anchor | Stryker Endoscopy | 2024-01-25 | 48 | 0 |
| K233327 | 1788 4K Camera System with Advanced Imaging Modality | Stryker Endoscopy | 2024-01-09 | 102 | 0 |
| K232683 | Knotilus+ PEEK Knotless Anchor | Stryker Endoscopy | 2023-10-24 | 53 | 0 |
| K231093 | AlphaVent Suture Anchors | Stryker Endoscopy | 2023-08-30 | 134 | 0 |
| K230886 | Connected OR Hub with Device and Voice Control; SDC4K Inform | Stryker Endoscopy | 2023-06-21 | 82 | 0 |
| K222079 | Connected OR Hub with Device and Voice Control, SDC4K Inform | Stryker Endoscopy | 2022-10-11 | 88 | 0 |
| K220108 | SDC4K Information Management System with Device and Voice Co | Stryker Endoscopy | 2022-02-09 | 27 | 0 |
| K211502 | Alpha Vent PEEK Suture Anchor | Stryker Endoscopy | 2021-08-04 | 82 | 0 |
| K210078 | Stryker ProCinch Adjustable Loop Device | Stryker Endoscopy | 2021-03-11 | 58 | 0 |
| K160332 | Stryker SDC3 HD Information Management System with Wireless | Stryker Endoscopy | 2016-05-18 | 100 | 0 |
| K151243 | STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Sourc | Stryker Endoscopy | 2015-08-20 | 101 | 0 |
| K150416 | ProCinch Adjustable Loop Device | Stryker Endoscopy | 2015-04-17 | 58 | 0 |
| K150127 | Laparoscopic Handles with peek Insulation | Stryker Endoscopy | 2015-02-04 | 15 | 0 |
| K142310 | Stryker Infrared Fluorescence (IRF) Imaging System | Stryker Endoscopy | 2014-12-02 | 105 | 0 |
| K142603 | Stryker Precision HD Camera System | Stryker Endoscopy | 2014-10-23 | 38 | 0 |
| K132785 | STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY | Stryker Endoscopy | 2013-12-16 | 101 | 3 |
| K130826 | PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATIN | Stryker Endoscopy | 2013-08-01 | 128 | 0 |
| K123441 | STRYKER CROSSFLOW ARTHROSCOPY PUMP | Stryker Endoscopy | 2013-01-09 | 62 | 0 |
| K121112 | STRYKER VIDEO URETEROSCOPE | Stryker Endoscopy | 2012-09-12 | 153 | 0 |
| K121893 | STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM | Stryker Endoscopy | 2012-09-05 | 68 | 0 |
| K093677 | STRYKER ARTHROSCOPE | Stryker Endoscopy | 2010-03-05 | 98 | 0 |
| K082451 | STRYKER VIDEOSCOPE | Stryker Endoscopy | 2008-12-16 | 113 | 0 |
| K081995 | STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV) | Stryker Endoscopy | 2008-10-02 | 80 | 0 |
| K071859 | STRYKER CROSSFIRE SYSTEM | Stryker Endoscopy | 2007-09-20 | 77 | 2 |
| K071157 | STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS | Stryker Endoscopy | 2007-09-17 | 145 | 5 |
| K070882 | STRYKER PEEK TWINLOOP TAC | Stryker Endoscopy | 2007-07-20 | 112 | 0 |
| K070758 | STRYKER PEEK ZIP SUTURE ANCHOR | Stryker Endoscopy | 2007-05-16 | 57 | 0 |
| K060085 | STRYKER SCOPE/INSTRUMENT HOLDER | Stryker Endoscopy | 2006-04-27 | 106 | 0 |
| K053311 | STRYKER SCOPE WARMER | Stryker Endoscopy | 2006-01-27 | 60 | 1 |
| K052141 | STRYKER STILETTO ELECTROSURGICAL PROBE | Stryker Endoscopy | 2005-10-06 | 59 | 3 |
| K043021 | STRYKER URETEROSCOPE | Stryker Endoscopy | 2005-03-16 | 133 | 0 |
| K043022 | STRYKER FLEXIBLE CYSTONEPHROSCOPE | Stryker Endoscopy | 2005-03-15 | 132 | 0 |
| K041810 | SERFAS ENERGY SYSTEM | Stryker Endoscopy | 2004-12-21 | 168 | 3 |
| K042454 | STRYKER CASSETTE PUMP | Stryker Endoscopy | 2004-12-09 | 90 | 4 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda