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510(k) K991426

MAHE INSTRUMENTS by Mahe Intl., Inc. — Product Code FDC

K991426 is an FDA 510(k) premarket notification submitted by Mahe Intl., Inc. for the device "MAHE INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on August 5, 1999. The device falls under product code FDC (Resectoscope, Working Element), a Class II device regulated under 21 CFR 876.1500. Mahe Intl., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1999
Date Received
April 23, 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

Other clearances by Mahe Intl., Inc.

  • K030857 — MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND END (October 16, 2003)
  • K942823 — MAHE INSTRUMENTS (December 5, 1994)

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)
  • 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