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510(k) K896754

I/A HANDPIECE by Advanced Surgical Products, Inc. — Product Code HQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1990
Date Received
November 30, 1989
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 Advanced Surgical Products, Inc.

  • K030926 — FAST THROW STAINLESS STEEL SURGICAL SUTURE (July 21, 2003)
  • K895800 — ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR (January 22, 1990)
  • K896305 — MULTI-USE I/A HANDPIECE (December 18, 1989)
  • K884557 — ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE (May 12, 1989)
  • K884556 — DREYER CURVED ENDOILLUMINATOR (February 28, 1989)
  • K890398 — RYAN-STYLE DIRECTED INFUSION MANIPULATOR (February 17, 1989)
  • K884347 — MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN (December 27, 1988)
  • K883857 — FIBEROPTIC WIRE PICK LIGHTPIPE (September 29, 1988)
  • K883858 — FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE (September 29, 1988)
  • K883856 — FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE (September 29, 1988)

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  • K170183 — Cetus system, Cetus probe (September 27, 2017)
  • K153168 — Bi-Blade Vitrectomy Cutter (April 29, 2016)
  • 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)