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510(k) K992141

OLYMPUS WORKING ELEMENT FOR PROBES by Olympus Winter & Ibe GmbH — Product Code FDC

K992141 is an FDA 510(k) premarket notification submitted by Olympus Winter & Ibe GmbH for the device "OLYMPUS WORKING ELEMENT FOR PROBES". The FDA issued a decision of Substantially Equivalent on September 29, 1999. The device falls under product code FDC (Resectoscope, Working Element), a Class II device regulated under 21 CFR 876.1500. Olympus Winter & Ibe GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1999
Date Received
June 24, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K231777 — Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessor (August 18, 2023)
  • K221522 — HF-cables (resusable) (January 19, 2023)
  • K223183 — Light-Guide Cables (January 13, 2023)
  • K213207 — Sheath, Stopcock Accessory (December 22, 2021)
  • K203492 — Instrument tray, for semi-rigid ureteroscope (September 15, 2021)
  • K210651 — Resection Electrodes with HF cable (August 3, 2021)
  • K203682 — Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer an (May 17, 2021)
  • K203277 — Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps (April 28, 2021)

Other clearances for product code FDC

  • K021166 — ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR (May 9, 2002)
  • K991426 — MAHE INSTRUMENTS (August 5, 1999)
  • K942626 — CONTINUOUS FLOW BIOPSY PROBE (May 30, 1995)
  • K933962 — GM CONTINUOUS FLOW BIOPSY PROBE (February 25, 1994)
  • K895643 — MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM (October 17, 1989)
  • K894363 — UROPUMP* FLUID MANAGEMENT SYSTEM (August 11, 1989)
  • K842997 — LASER RECTOSCOPE SET 784 (August 27, 1984)
  • K760184 — ELEMENT, WORKING (December 2, 1976)
  • K760182 — SHEATH, RESECTOSCOPE (December 2, 1976)
  • K760174 — ADAPTER, RESECTOSCOPE (August 30, 1976)

FDA data resources