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510(k) K896562

STOPCOCK by Westmark, Sterile Packing Systems, Inc. (Sps) — Product Code GCX

K896562 is an FDA 510(k) premarket notification submitted by Westmark, Sterile Packing Systems, Inc. (Sps) for the device "STOPCOCK". The FDA issued a decision of Substantially Equivalent on February 6, 1990. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Westmark, Sterile Packing Systems, Inc. (Sps) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1990
Date Received
November 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Westmark, Sterile Packing Systems, Inc. (Sps)

  • K896800 — IRRIGATION TRAY (May 24, 1990)
  • K896799 — PARACERVICAL/PUDENDAL TRAYS (April 23, 1990)
  • K896559 — INFANT FEEDING TUBE (March 13, 1990)
  • K896794 — SPECIMEN CONTAINER (March 1, 1990)
  • K896806 — CATHETER PLUG/PROTECTOR (February 26, 1990)
  • K896798 — TRACHEOSTOMY TRAY (February 22, 1990)
  • K896797 — SUCTION CATHETER KIT (February 16, 1990)
  • K896215 — MERCY HIP/KNEE PACK (February 13, 1990)
  • K896804 — MANIFOLD (February 8, 1990)
  • K896557 — YANKAUER SUCTION TUBE-FLEXIBLE TYPE (February 6, 1990)

Other clearances for product code GCX

  • K042454 — STRYKER CASSETTE PUMP (December 9, 2004)
  • K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (August 3, 1999)
  • K972074 — SUCTION INSTRUMENTATION (July 25, 1997)
  • K971022 — CHASE SUCKER (April 17, 1997)
  • K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (December 31, 1996)
  • K964519 — CURITY THORACENTESIS TRAY (December 20, 1996)
  • K963648 — STRYKER SUCTION REGULATOR (November 26, 1996)
  • K962920 — RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (October 21, 1996)
  • K961880 — MEDCARE SUCTION CONNECTING TUBING (July 19, 1996)
  • K960223 — CPR YANKAUER (March 28, 1996)

FDA data resources