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510(k) K895813

GLAUCOMA MECHANICAL TREPHINE by Trek Medical Products, Inc. — Product Code HQE

K895813 is an FDA 510(k) premarket notification submitted by Trek Medical Products, Inc. for the device "GLAUCOMA MECHANICAL TREPHINE". The FDA issued a decision of Substantially Equivalent on April 30, 1990. 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
April 30, 1990
Date Received
October 2, 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 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)
  • K882403 — OPHTHALMIC FLUID INJECTOR (September 9, 1988)
  • K875195 — OPHTHALMIC LIGHT PIPE PICK (March 7, 1988)
  • K864035 — VES-10 INTRAOCULAR SCISSORS DRIVE (December 15, 1986)

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