STRYKER ENDOSCOPIC INSTRUMENTS AND ACCESSORIES— 510(k) K935237
Substantially EquivalentStryker Endoscopy
FDA 510(k) clearance K935237 for STRYKER ENDOSCOPIC INSTRUMENTS AND ACCESSORIES, Substantially Equivalent on 1994-03-21. Applicant: Stryker Endoscopy. Device class: 2.
Clearance details
- Applicant
- Stryker Endoscopy
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code GEI
view allMore clearances from Stryker Endoscopy
view all- K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down
- DEN250040 — SportSuite Vision Software
- K253602 — Precision S 4K Sinuscope
- K261037 — 780 nm SPY Portable Handheld Imaging (SPY-PHI) System
- K260185 — 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K935237
K-number listed on FDA's recall record- Z-1544-2014 — 12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held. The tray features silicon device holders that secure devices during the sterilization process.
- Z-1961-2012 — Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA The Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the sterilization process. Specifically this tray is used for arthroscopes and arthroscopic hardware devices. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K935237.
Data sourced from openFDA. This site is unofficial and independent of the FDA.