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510(k) K820765

PLEURAL DRAINAGE RESERVOIR by Innovative Surgical Products, Inc. — Product Code GCX

K820765 is an FDA 510(k) premarket notification submitted by Innovative Surgical Products, Inc. for the device "PLEURAL DRAINAGE RESERVOIR". The FDA issued a decision of Substantially Equivalent on April 15, 1982. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Innovative Surgical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1982
Date Received
March 22, 1982
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 Innovative Surgical Products, Inc.

  • K843041 — HESLIN DISPOS. TUBING SET (November 21, 1984)
  • K840693 — DISPOSABLE SCLERAL GLOBE PLUG (May 22, 1984)
  • K840695 — PHACOEMULSIFICATION KITS (May 22, 1984)
  • K840694 — LENS INSERTION GLIDE (May 9, 1984)
  • K841072 — IRRIGATION, ASPIRATION TUBING SETS (March 29, 1984)
  • K832235 — DISPOSABLE VITRECTOMY HANDPIECE (September 29, 1983)
  • K821496 — DISPOSABLE IRRIGA/ASPIR. SYSTEM (June 22, 1982)
  • K820680 — DISPOSABLE TUBING SETS (April 9, 1982)
  • K802973 — ISPVAC TM (December 19, 1980)
  • K801350 — ACUVAC(TM) SUCTION RESERVOIR 400CC AND (July 14, 1980)

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