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510(k) K894363

UROPUMP* FLUID MANAGEMENT SYSTEM by Orthoconcept, Inc. — Product Code FDC

K894363 is an FDA 510(k) premarket notification submitted by Orthoconcept, Inc. for the device "UROPUMP* FLUID MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on August 11, 1989. The device falls under product code FDC (Resectoscope, Working Element), a Class II device regulated under 21 CFR 876.1500. Orthoconcept, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1989
Date Received
July 14, 1989
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

Other clearances by Orthoconcept, Inc.

  • K925160 — ARTHRO FMS 4 (February 17, 1994)
  • K910164 — ORTHOCONCEPT ARTHROSCOPIC PUMP (March 27, 1991)
  • K905785 — ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS) (March 26, 1991)
  • K896196 — ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR (December 1, 1989)
  • K895643 — MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM (October 17, 1989)
  • K882469 — CORDEX SHAVER, BLADES, RECHARGER AND BATTERIES (December 1, 1988)
  • K872270 — ORTHOCONCEPT ARTHROSCOPIC PUMP ORTHOPUMP (July 21, 1987)

Other clearances for product code FDC

  • K021166 — ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR (May 9, 2002)
  • K992141 — OLYMPUS WORKING ELEMENT FOR PROBES (September 29, 1999)
  • 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)
  • 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