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510(k) K760174

ADAPTER, RESECTOSCOPE by V. Mueller O.V. Baxter Healthcare Corp. — Product Code FDC

K760174 is an FDA 510(k) premarket notification submitted by V. Mueller O.V. Baxter Healthcare Corp. for the device "ADAPTER, RESECTOSCOPE". The FDA issued a decision of Substantially Equivalent on August 30, 1976. The device falls under product code FDC (Resectoscope, Working Element), a Class II device regulated under 21 CFR 876.1500. V. Mueller O.V. Baxter Healthcare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1976
Date Received
July 6, 1976
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 V. Mueller O.V. Baxter Healthcare Corp.

  • K803292 — FIELD SUCTION DISSECTOR (January 29, 1981)
  • K792383 — KELMAN DIPSTICK (December 11, 1979)
  • K771197 — NORTON ENDOTRACHEAL (August 16, 1977)
  • K771302 — PFISTER-SCHWARTZ STONE RETRIEVER (August 2, 1977)
  • K770959 — BOUGIE, FILIFORM, JACKSON (June 14, 1977)
  • K770280 — CORD, ELECTROSURGICAL-STERILE & DISPOS. (April 15, 1977)
  • K760851 — CONVERSE ALTAR RETRACTOR (March 10, 1977)
  • K761242 — TEFLON COATED RESECTOSCOPE SHEATH (December 16, 1976)
  • K760273 — LITHOTRITE (December 6, 1976)
  • K760182 — SHEATH, RESECTOSCOPE (December 2, 1976)

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)
  • 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)

FDA data resources