# K971305: Femrx Focused Monopolar (FMP) Opera Star System

- Pathway: 510(k) (Traditional)
- Applicant: Gynecare Innovation Center
- Decided: Aug 11, 1997 after 125 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964441 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964441: Femrx Focused Monopolar (Fap) Operastar System [Outpatient Endoscopic Resection and Ablation (Opera)] [Specialized Tissu, Gynecare Innovation Center (1997) Summary page 1.

## Indications for use
The FemRx™ Focused Monopolar (FMP) ®***STAR™ System is intended for gynecologic hysteroscopic / electro-surgical use by trained professional gynecologists in hospital or office environments. It is used to resect and / or ablate endometrial tissue.

Source page: https://510kreport.com/device/K971305
Methodology: https://510kreport.com/methodology