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510(k) K962920

RENTON SUCTION DEVICE U.S. PATENT*4,767,404 by R&S Surgical, LLC — Product Code GCX

K962920 is an FDA 510(k) premarket notification submitted by R&S Surgical, LLC for the device "RENTON SUCTION DEVICE U.S. PATENT*4,767,404". The FDA issued a decision of Substantially Equivalent on October 21, 1996. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1996
Date Received
July 26, 1996
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 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)
  • K961880 — MEDCARE SUCTION CONNECTING TUBING (July 19, 1996)
  • K960223 — CPR YANKAUER (March 28, 1996)
  • K954869 — MEDCARE YANKAUER SUCTION DEVICE (January 19, 1996)

FDA data resources