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510(k) K832235

DISPOSABLE VITRECTOMY HANDPIECE by Innovative Surgical Products, Inc. — Product Code HQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1983
Date Received
July 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

Other clearances by Innovative Surgical Products, Inc.

  • K843041 — HESLIN DISPOS. TUBING SET (November 21, 1984)
  • K840695 — PHACOEMULSIFICATION KITS (May 22, 1984)
  • K840693 — DISPOSABLE SCLERAL GLOBE PLUG (May 22, 1984)
  • K840694 — LENS INSERTION GLIDE (May 9, 1984)
  • K841072 — IRRIGATION, ASPIRATION TUBING SETS (March 29, 1984)
  • K821496 — DISPOSABLE IRRIGA/ASPIR. SYSTEM (June 22, 1982)
  • K820765 — PLEURAL DRAINAGE RESERVOIR (April 15, 1982)
  • K820680 — DISPOSABLE TUBING SETS (April 9, 1982)
  • K802973 — ISPVAC TM (December 19, 1980)
  • K801350 — ACUVAC(TM) SUCTION RESERVOIR 400CC AND (July 14, 1980)

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  • K141065 — CONSTELLATION VISION SYSTEM (August 22, 2014)
  • K121675 — VERSAVIT (June 21, 2012)
  • K120170 — PROCARE PLUS VITRECTOMY SYSTEM (May 30, 2012)
  • K102222 — ULTIMATE VIT ENHAMCER (UVE) (April 8, 2011)
  • K033390 — COLIBRI DISPOSABLE VITRECTOMY CUTTER (November 4, 2003)
  • K030948 — VMATE MODEL VMM1000 (June 17, 2003)
  • K023939 — VELOCITY ADVANTAGE (April 17, 2003)