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510(k) K810739

SUCTION WOUND DRAINAGE DEVICE by The Urology Group — Product Code KQT

K810739 is an FDA 510(k) premarket notification submitted by The Urology Group for the device "SUCTION WOUND DRAINAGE DEVICE". The FDA issued a decision of Substantially Equivalent on June 26, 1981. The device falls under product code KQT (Evacuator, Gastro-Urology), a Class II device regulated under 21 CFR 876.4370. The Urology Group has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1981
Date Received
March 19, 1981
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 by The Urology Group

  • K831703 — COVERUPS (January 3, 1984)
  • K831489 — SURGICAL TUBE HOLDER (December 12, 1983)
  • K810788 — SURGICAL TUBE HOLDER (April 17, 1981)
  • K810787 — UROLOGIC TUBE HOLDER (March 31, 1981)
  • K801629 — COVER-ALL MALE INCONTINENCE DEVICE (August 12, 1980)

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)
  • K910728 — CLEANFLOW SYSTEM (April 1, 1991)
  • 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)
  • K801781 — CATHETER IRRIGATION SYRINGES, #3100,3110 (August 13, 1980)

FDA data resources