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510(k) K791182

ACMI RIGI-FLEX NEPHORSCOPE by American Cystocope Makers, Inc. — Product Code FGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1979
Date Received
June 25, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Nephroscope
Device Class
Class II
Regulation Number
876.1500
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)
  • K803214 — ACMI BIPOLAR HEMOSTATIC ELECTRODE (January 15, 1981)
  • 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 FGA

  • K232370 — Percutaneous Nephroscope System (May 1, 2024)
  • K151308 — Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set (February 9, 2016)
  • K072594 — GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM (December 13, 2007)
  • K994223 — NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 (June 5, 2000)
  • K950433 — KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES (March 15, 1995)
  • K940594 — KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE (September 9, 1994)
  • K922826 — FLEXIBLE FIBER OPTIC ENDOSCOPE (February 19, 1993)
  • K853486 — OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE (September 12, 1985)
  • K770729 — PYELOSCOPE SYSTEM (April 28, 1977)