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510(k) K770754

DUODENOSCOPE, MOLEL TX-6 by American Cystocope Makers, Inc. — Product Code FOG

K770754 is an FDA 510(k) premarket notification submitted by American Cystocope Makers, Inc. for the device "DUODENOSCOPE, MOLEL TX-6". The FDA issued a decision of Substantially Equivalent on April 28, 1977. The device falls under product code FOG (Hood, Oxygen, Infant), a Class I device regulated under 21 CFR 868.5700. American Cystocope Makers, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1977
Date Received
April 25, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hood, Oxygen, Infant
Device Class
Class I
Regulation Number
868.5700
Review Panel
AN
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)
  • K791182 — ACMI RIGI-FLEX NEPHORSCOPE (July 30, 1979)
  • 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 FOG

  • K973128 — OLYMPUS NA-10J-1 ASPIRATION NEEDLE (November 18, 1997)
  • K962182 — BURLEW INFANT HOOD (July 15, 1996)
  • K955482 — SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION) (January 30, 1996)
  • K830781 — ENDO-GUARD (March 31, 1983)
  • K792144 — DISPOSA-HOOD (December 5, 1979)
  • K791861 — OXYGEN HOODS (October 4, 1979)
  • K790860 — RT-HOOD (May 29, 1979)
  • K780220 — HOOD, INFANT OXYGEN (April 10, 1978)

FDA data resources