Home / 510(k) Clearances / K791182

510(k) K791182

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

K791182 is an FDA 510(k) premarket notification submitted by American Cystocope Makers, Inc. for the device "ACMI RIGI-FLEX NEPHORSCOPE". The FDA issued a decision of Substantially Equivalent on July 30, 1979. The device falls under product code FGA (Kit, Nephroscope), a Class II device regulated under 21 CFR 876.1500. American Cystocope Makers, Inc. has at least 8 other 510(k) clearances on record.

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)
  • K760452 — COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92) (August 30, 1976)
  • K760451 — AIR WATER SOURCE (ACMI MODEL 710) (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)

FDA data resources