510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964441Substantially Equivalent

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

Gynecare Innovation Center, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964441 is the FDA 510(k) clearance record for FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU, a class II device, cleared for Gynecare Innovation Center on under FDA product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)). FDA records list 8 510(k) clearances for Gynecare Innovation Center, from to . As of , FDA records show no recalls naming K964441.

Clearance record

Decision date
Received
(142 days to decision)
Product code
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Regulation
21 CFR 884.4160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Gynecare Innovation Center 1221 Innsbruck Dr., Sunnyvale CA
510(k) summary
Summary
Third party review
No

Clearances, product code KNF

Trailing 12 months
1 clearance under product code KNF in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260