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510(k) K910728

CLEANFLOW SYSTEM by Mitron Technologies, Inc. — Product Code KQT

K910728 is an FDA 510(k) premarket notification submitted by Mitron Technologies, Inc. for the device "CLEANFLOW SYSTEM". The FDA issued a decision of Substantially Equivalent on April 1, 1991. The device falls under product code KQT (Evacuator, Gastro-Urology), a Class II device regulated under 21 CFR 876.4370.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1991
Date Received
February 20, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Evacuator, Gastro-Urology
Device Class
Class II
Regulation Number
876.4370
Review Panel
GU
Submission Type

Other clearances for product code KQT

  • K964111 — LITHOVAC SUCTION/ASPIRATION PROBE (December 16, 1996)
  • K921088 — EVACUATOR, GASTRO-UROLOGY (October 28, 1992)
  • K921451 — EVACUATOR, GASTRO-UROLOGY (October 28, 1992)
  • K880099 — VAN-TEC BLADDER EVACUATOR (March 2, 1988)
  • K874493 — BELLA - VAC IRRIGATOR (February 5, 1988)
  • K860266 — ELLIK EVACUATOR (March 5, 1986)
  • K830546 — DOSIMETRIC RELEASE (May 25, 1983)
  • K811779 — ROSS-EMERSON PUMP, MODEL 55-R (July 13, 1981)
  • K810739 — SUCTION WOUND DRAINAGE DEVICE (June 26, 1981)
  • K801781 — CATHETER IRRIGATION SYRINGES, #3100,3110 (August 13, 1980)

FDA data resources