510(k) K760822

MODEL TX-8 PANENDOSCOPE by American Cystocope Makers, Inc. — Product Code FAK

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 21, 1976
Date Received: October 13, 1976
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Panendoscope (Gastroduodenoscope)
Device Class: Class II
Regulation Number: 876.1500
Review Panel: GU
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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)
K760451 — AIR WATER SOURCE (ACMI MODEL 710) (August 30, 1976)
K760452 — COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92) (August 30, 1976)

510(k) K760822

Clearance Details

Device Classification

Other clearances by American Cystocope Makers, Inc.

Other clearances for product code FAK