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510(k) K760452

COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92) by American Cystocope Makers, Inc. — Product Code FDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1976
Date Received
August 16, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colonoscope And Accessories, Flexible/Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To examine or perform procedures in the colon or rectum For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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)
  • 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)

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  • K244029 — ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) (September 24, 2025)
  • K243261 — FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM (May 23, 2025)
  • K250432 — Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal (May 15, 2025)
  • K242110 — PENTAX Medical Video Colonoscope (EC38-i20cWL) (January 3, 2025)
  • K242325 — GripTract-GI Endoscopic Tissue Manipulator Lower GI Models (October 4, 2024)
  • K232043 — Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, (February 16, 2024)
  • K231254 — GripTract-GI Endoscopic Tissue Manipulator (November 3, 2023)
  • K232922 — Pure-Vu EVS System (October 20, 2023)
  • K230332 — Ambu® aScope™ Colon; Ambu® aBox™ 2 (September 15, 2023)