Stryker Laparoscope
510(k) K910132
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK910132 | Date21 Feb 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GCJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Stryker Laparoscope is an endoscopic instrument designed for visual inspection and imaging during minimally invasive surgical procedures. It provides optical transmission through a rod lens system to deliver clear images to the operating team.
The device is supplied as a reusable, autoclavable instrument and is available in configurations such as a 0° viewing angle, 5.4 mm diameter and 30 cm working length. It has been cleared by the U.S. FDA through a traditional 510(k) submission (K910132) as substantially equivalent to a predicate device.
Other devices from Stryker Corp.
Questions
AI-generated answers, 27 Sep 2026
What viewing angle and size does the Stryker Laparoscope offer?
It provides a 0° viewing angle, a 5.4 mm outer diameter, and a 30 cm working length, which together give a compact profile suitable for a wide range of minimally invasive procedures while maintaining a clear line of sight.
Is the instrument intended for single‑use or can it be reused?
The laparoscope is supplied as a reusable device. It is constructed to withstand standard autoclave cycles, allowing it to be sterilized and safely re‑used according to the manufacturer’s reprocessing guidelines.
How was the device cleared for market?
It received traditional 510(k) clearance (K910132) by demonstrating substantial equivalence to a predicate endoscopic instrument, meaning the FDA determined it offers comparable safety and performance for its intended use.
What clinical specialties is the device associated with?
The advisory committee review listed gastroenterology and urology, indicating the laparoscope is intended for procedures within those specialties that require high‑quality visualisation of internal anatomy.