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510(k) K950287

UNIVIT PROBE by Medical Instrument Development Laboratories, Inc. — Product Code HKP

K950287 is an FDA 510(k) premarket notification submitted by Medical Instrument Development Laboratories, Inc. for the device "UNIVIT PROBE". The FDA issued a decision of Substantially Equivalent on April 10, 1995. The device falls under product code HKP (Instrument, Vitreous Aspiration And Cutting, Battery-Powered), a Class II device regulated under 21 CFR 886.4150. Medical Instrument Development Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1995
Date Received
January 24, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Medical Instrument Development Laboratories, Inc.

  • K153168 — Bi-Blade Vitrectomy Cutter (April 29, 2016)
  • K102222 — ULTIMATE VIT ENHAMCER (UVE) (April 8, 2011)
  • K020911 — MID LABS AUTONOMOUS VIT ENHANCER (AVE) (April 29, 2002)
  • K992943 — VIT ENHANCER (December 10, 1999)
  • K971067 — DIGI-INJECTOR (September 19, 1997)
  • K934600 — MICRODRIVE (July 27, 1994)
  • K932669 — SUPRA-VIT(TM) (June 3, 1994)
  • K932131 — MID LABS TWIN ILLUMINATOR (April 1, 1994)
  • K924222 — MID LABS, INC. VIT MATE (January 27, 1993)
  • K851610 — COMBINED MVS SYSTEMS (July 22, 1985)

Other clearances for product code HKP

  • K952558 — AARON VAC 2 (March 19, 1997)
  • K950056 — THE GRIESHABER AXIAL CUTTER (May 5, 1995)
  • K896622 — VISITEC VITRECTOMY UNIT (April 4, 1990)
  • K890595 — MENTOR ANTERIOR SEGMENT VITRECTOR (April 17, 1989)
  • K832074 — CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA (August 1, 1983)
  • K822599 — KEATES I/A SYSTEM FRIGITRONICS 4000 (October 6, 1982)
  • K813273 — EMERGENCY POWER PAC (EMPAC) (December 31, 1981)
  • K810152 — X-VEE (March 17, 1981)
  • K801231 — EYE-VAC (July 21, 1980)
  • K791898 — OCUTOME MODEL 8000 (October 30, 1979)

FDA data resources