Home / 510(k) Clearances / K971305

510(k) K971305

FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM by Gynecare Innovation Center — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1997
Date Received
April 8, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

Other clearances by Gynecare Innovation Center

  • K980393 — SOPRANO CRYO-THERAPY SYSTEM (May 1, 1998)
  • K964441 — FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION (March 28, 1997)
  • K964892 — FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) (February 4, 1997)
  • K963872 — FEMRX MORCELLATOR SYSTEM (January 17, 1997)
  • K962506 — [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] (September 16, 1996)
  • K954775 — FLO-STAT FLUID MONITORING SYSTEM (May 10, 1996)
  • K954648 — FEMRX OPERASTAR SYSTEM (March 14, 1996)

Other clearances for product code HIH

  • K254251 — InnovexView (GC146-17, GC150-20, GC155-23) (February 26, 2026)
  • K252793 — ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysterosc (December 18, 2025)
  • K252012 — SPY Cystoscope/Hysteroscope (July 18, 2025)
  • K243382 — RZ Resectoscope System (June 3, 2025)
  • K240978 — SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, H (August 16, 2024)
  • K241987 — Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) (August 2, 2024)
  • K240401 — ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS- (July 26, 2024)
  • K231260 — HTx Disposable Hysteroscope System (March 5, 2024)
  • K233635 — SPY Cystoscope/Hysteroscope (February 12, 2024)
  • K232003 — Endoscopic Video Image Processor, Single-Use Video Hysteroscope (February 12, 2024)