Gynescope Laparoscopic Forceps
510(k) K902657
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK902657 | Date19 Sep 1990 | 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- Withdrawn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
- HET
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1720
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Gynescope Laparoscopic Forceps is a laparoscopic instrument used for grasping, manipulating, and dissecting tissues during laparoscopic procedures. It is designed for use in obstetrics and gynecology surgeries.
The device is supplied as a Class II medical device with FDA 510(k) clearance K902657, granted on September 19, 1990. It is manufactured by Gynescope Corp. and is not specified as single-use or reusable in the provided data.
Other devices from Gynescope Corp.
Questions
AI-generated answers, 6 Oct 2026
What is the Gynescope Laparoscopic Forceps used for?
The Gynescope Laparoscopic Forceps is a specialized instrument designed for grasping, manipulating, and dissecting tissues during laparoscopic procedures, specifically in obstetrics and gynecology surgeries.
Is the Gynescope Laparoscopic Forceps single-use or reusable?
The device data does not specify whether the Gynescope Laparoscopic Forceps is intended for single-use or reusable purposes. This information should be confirmed with the manufacturer or product instructions.
What is the regulatory status of the Gynescope Laparoscopic Forceps?
The Gynescope Laparoscopic Forceps is a Class II medical device with FDA 510(k) clearance K902657, granted on September 19, 1990, and is manufactured by Gynescope Corp. It is substantially equivalent to other devices in its product code category HET.
How is the Gynescope Laparoscopic Forceps supplied?
The device is supplied as a Class II medical device with FDA 510(k) clearance. The specific packaging and sterilization details are not provided in the available data.