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510(k) K803214

ACMI BIPOLAR HEMOSTATIC ELECTRODE by American Cystocope Makers, Inc. — Product Code FEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1981
Date Received
December 18, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Flexible Suction Coagulator
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by American Cystocope Makers, Inc.

  • K832040 — STERILE FLUID PRODUCING UNIT #EP550 (September 29, 1983)
  • K812637 — ACMI BIPOLAR HEMOSTATIC SOURCE (October 26, 1981)
  • K811218 — ACMI ASPIRATOR KIT #8808 (July 1, 1981)
  • K791182 — ACMI RIGI-FLEX NEPHORSCOPE (July 30, 1979)
  • K770754 — DUODENOSCOPE, MOLEL TX-6 (April 28, 1977)
  • K760822 — MODEL TX-8 PANENDOSCOPE (October 21, 1976)
  • K760451 — AIR WATER SOURCE (ACMI MODEL 710) (August 30, 1976)
  • K760452 — COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92) (August 30, 1976)

Other clearances for product code FEH

  • K130489 — ELECTRODE, FLEXIBLE SUCTION COAGULATOR (April 19, 2013)
  • K122593 — PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI- (September 13, 2012)