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510(k) K860266

ELLIK EVACUATOR by R. J. Ltd., Ind. — Product Code KQT

K860266 is an FDA 510(k) premarket notification submitted by R. J. Ltd., Ind. for the device "ELLIK EVACUATOR". The FDA issued a decision of Substantially Equivalent on March 5, 1986. The device falls under product code KQT (Evacuator, Gastro-Urology), a Class II device regulated under 21 CFR 876.4370. R. J. Ltd., Ind. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1986
Date Received
January 27, 1986
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 R. J. Ltd., Ind.

  • K860265 — TELESCOPE PROTECTION TUBE (April 7, 1986)

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)
  • 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