# K935237: Stryker Endoscopic Instruments and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Mar 21, 1994 after 140 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K081553: Aed Bipolar Forceps, Model 13-1646 (2008), 0 descendants of its own
- K061225: Stryker Disposable Laparoscopic Scissors (2006), 0 descendants of its own

## Recalls of this device
- Apr 16, 2014 · Class II · Z-1544-2014: Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.
- Jun 19, 2012 · Class II · Z-1961-2012: The gravity steam, Ethylene Oxide (EO) and STERRAD 100S sterilization methods are being removed from the "Instructions for Use"; due to the firm's evaluation that identified original validation was no

Source page: https://510kreport.com/device/K935237
Methodology: https://510kreport.com/methodology