# K964441: Femrx Focused Monopolar (Fap) Operastar System [Outpatient Endoscopic Resection and Ablation (Opera)] [Specialized Tissu

- Pathway: 510(k) (Traditional)
- Applicant: Gynecare Innovation Center
- Decided: Mar 28, 1997 after 142 days
- Product code: KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
39 later devices descend from it; 2 cite it directly.
0 of 40 devices 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) STAR System resectoscope: named in the summary without a submission number

## Most influential descendants
- K031787: Smith & Nephew Iur Morcellation System (2003), 37 descendants of its own
- K041774: Iur Reciprocating Morcellator Model # 7210517 (2004), 34 descendants of its own
- K110038: Truclear Morcellator System (2011), 25 descendants of its own
- K103389: Truclear Incisor Plus Blade 2.9 (2011), 25 descendants of its own
- K132015: Truclear Morcellation System and Truclear Morcellators (2013), 24 descendants of its own

Source page: https://510kreport.com/device/K964441
Methodology: https://510kreport.com/methodology