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510(k) K864035

VES-10 INTRAOCULAR SCISSORS DRIVE by Trek Medical Products, Inc. — Product Code HQE

K864035 is an FDA 510(k) premarket notification submitted by Trek Medical Products, Inc. for the device "VES-10 INTRAOCULAR SCISSORS DRIVE". The FDA issued a decision of Substantially Equivalent on December 15, 1986. The device falls under product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered), a Class II device regulated under 21 CFR 886.4150. Trek Medical Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1986
Date Received
October 16, 1986
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 Trek Medical Products, Inc.

  • K920937 — COMPUTERIZED PUPIL (October 2, 1992)
  • K920944 — FTS-200 GAS SYSTEM (May 29, 1992)
  • K900808 — RAPID AUTOMATIC PNEUMOPERITONEUM-I (September 19, 1990)
  • K902784 — FIBER OPTIC LIGHT SOURCE (September 12, 1990)
  • K895813 — GLAUCOMA MECHANICAL TREPHINE (April 30, 1990)
  • K882403 — OPHTHALMIC FLUID INJECTOR (September 9, 1988)
  • K875195 — OPHTHALMIC LIGHT PIPE PICK (March 7, 1988)

Other clearances for product code HQE

  • K212763 — UniVit HE, UniVit UHS (August 10, 2022)
  • 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)

FDA data resources