Skip to content

Femrx Turp Sr System (TS27XX-Yy/TS24XX-Yy)

by Gynecare Innovation Center

510(k) K964892

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK964892 Date4 Feb 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FJL
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The FemRx TURP SR System (TS27XX-YY/TS24XX-YY) is a resectoscope, classified under product code FJL, designed for transurethral resection procedures. It is intended for use in urological applications to remove tissue from the bladder or prostate under direct visualisation via an endoscope.

This system is supplied as a reusable medical device and is intended for use in hospital environments by trained professionals. It has received FDA 510(k) clearance under the regulation number 876.1500, with a decision of Substantially Equivalent (SESE) issued on February 4, 1997. The device is regulated under Class II special controls and is associated with the Gastroenterology and Urology advisory committees.

Other devices from Gynecare Innovation Center

See all devices from Gynecare Innovation Center →