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510(k) K964892

FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) by Gynecare Innovation Center — Product Code FJL

K964892 is an FDA 510(k) premarket notification submitted by Gynecare Innovation Center for the device "FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)". The FDA issued a decision of Substantially Equivalent on February 4, 1997. The device falls under product code FJL (Resectoscope), a Class II device regulated under 21 CFR 876.1500. Gynecare Innovation Center has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1997
Date Received
December 6, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resectoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Gynecare Innovation Center

  • K980393 — SOPRANO CRYO-THERAPY SYSTEM (May 1, 1998)
  • K971305 — FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM (August 11, 1997)
  • K964441 — FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION (March 28, 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 FJL

  • K232486 — KARL STORZ Monopolar Resectoscopes with HF Cable (May 7, 2024)
  • K221893 — KARL STORZ Bipolar Resectoscopes with HF Cable (March 17, 2023)
  • K230205 — Veloxion System (February 24, 2023)
  • K191341 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Velo (June 13, 2019)
  • K190099 — Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Velo (March 15, 2019)
  • K162979 — Veloxion System (March 24, 2017)
  • K102663 — AED RESECTOSCOPE (December 30, 2010)
  • K062720 — S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES (March 22, 2007)
  • K042523 — RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSOR (March 18, 2005)
  • K041610 — MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 (August 19, 2004)

FDA data resources