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510(k) K801782

GENERAL PURPOSE IRRIGATING/ASPIR SYR. by The Healthcare Group Laboratories, Inc. — Product Code KQT

K801782 is an FDA 510(k) premarket notification submitted by The Healthcare Group Laboratories, Inc. for the device "GENERAL PURPOSE IRRIGATING/ASPIR SYR.". The FDA issued a decision of Substantially Equivalent on August 13, 1980. The device falls under product code KQT (Evacuator, Gastro-Urology), a Class II device regulated under 21 CFR 876.4370. The Healthcare Group Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1980
Date Received
July 28, 1980
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 Healthcare Group Laboratories, Inc.

  • K850035 — EMPTY SOLUTION TRANSFER CONTAINER (June 7, 1985)
  • K842170 — EMPTY SOLUTION TRANSFER CONTAINER (October 19, 1984)
  • K842091 — DISPOS. ACU-CUT SOFT TISSUE BIOPSY (July 23, 1984)
  • K840742 — RIGHT ATRIAL CATHETER (July 13, 1984)
  • K830299 — SOLUTION TRANSFER CONTAINER (February 19, 1983)
  • K822307 — ADHESIVE SPRAY #4050-4060 (September 24, 1982)
  • K822059 — SHOW'RBAG (July 22, 1982)
  • K821480 — RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT (June 17, 1982)
  • K821230 — SOFTIC 49 (May 28, 1982)
  • K821162 — ADHESIVE REMOVER (May 14, 1982)

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