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510(k) K791306

ELLIK EVACUATOR by Davol, Inc. — Product Code KQT

K791306 is an FDA 510(k) premarket notification submitted by Davol, Inc. for the device "ELLIK EVACUATOR". The FDA issued a decision of Substantially Equivalent on August 3, 1979. The device falls under product code KQT (Evacuator, Gastro-Urology), a Class II device regulated under 21 CFR 876.4370. Davol, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1979
Date Received
July 16, 1979
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 Davol, Inc.

  • K251557 — Bard® Mesh; Bard® Mesh Pre-Shaped (June 12, 2025)
  • K250098 — Bard Soft Mesh; Bard Soft Mesh Pre-Shaped (April 9, 2025)
  • K031213 — AQUASENS FLUID MONITORING SYSTEM (April 30, 2003)
  • K030307 — DAVOL ARTHROVENT OUTFLOW TUBING (February 13, 2003)
  • K003323 — COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 (January 22, 2001)
  • K003790 — DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, (December 22, 2000)
  • K931899 — DAVOL ATS (November 15, 1994)
  • K941334 — DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE (June 14, 1994)
  • K921405 — DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP (March 25, 1994)
  • K935503 — DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET (March 7, 1994)

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)
  • K810739 — SUCTION WOUND DRAINAGE DEVICE (June 26, 1981)

FDA data resources