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510(k) K791400

GASTRIC LAVAGE KIT-DISPOSABLE by Acumed Instruments Corp. — Product Code GBQ

K791400 is an FDA 510(k) premarket notification submitted by Acumed Instruments Corp. for the device "GASTRIC LAVAGE KIT-DISPOSABLE". The FDA issued a decision of Substantially Equivalent on August 16, 1979. The device falls under product code GBQ (Catheter, Continuous Irrigation), a Class I device regulated under 21 CFR 878.4200. Acumed Instruments Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1979
Date Received
July 16, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Acumed Instruments Corp.

  • K863627 — MICRO SURGICAL DRILL SYSTEM (October 2, 1986)
  • K853659 — POWERED IRRIGATION FOR MICRO SURGICAL DRILL (September 24, 1985)
  • K853660 — MICRO SURGICAL DRILL SYSTEM (September 24, 1985)
  • K853658 — BURS FOR MICRO SURGICAL DRILL SYSTEM (September 24, 1985)
  • K791891 — ACU-MED RED MISER HEMOTHORAX BLOOD COLL. (December 5, 1979)
  • K791399 — ACU-ALERT (October 11, 1979)
  • K790901 — I.V. TUBING ORGANIZER (June 27, 1979)

Other clearances for product code GBQ

  • K941356 — MICROFLOW IRRIGATION SYSTEM (May 19, 1994)
  • K921464 — CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT (May 5, 1992)
  • K882647 — GESCO CATHETERIZATION TRAY (September 9, 1988)
  • K874596 — PERFORATED SOAKING TUBE (December 2, 1987)
  • K873097 — PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS (September 4, 1987)
  • K872787 — MODIFIED CURLCATH (August 4, 1987)
  • K771732 — THORNTON ANTERIOR CHAMBER IRRIGATOR (September 28, 1977)

FDA data resources