# K964892: Femrx Turp SR System (TS27XX-YY/TS24XX-YY)

- Pathway: 510(k) (Traditional)
- Applicant: Gynecare Innovation Center
- Decided: Feb 4, 1997 after 60 days
- Product code: FJL (Resectoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) FemRx TURPSTAR™ System: named in the summary without a submission number
- (no number) Circon/ACMI USA Elite™: named in the summary without a submission number
- (no number) Olympus A2757 Resectosope: named in the summary without a submission number

## Indications for use
The FemRx TURPSR™ System is intended for urological transurethral resection by trained professional urologists in hospital environments. This device is intended for resection of tissue in the urethra, prostate and bladder.

Source page: https://510kreport.com/device/K964892
Methodology: https://510kreport.com/methodology