Cleared Traditional

UNIVIT PROBE

K950287 · Medical Instrument Development Laboratories, Inc. · Ophthalmic

Apr 1995

Decision

76d

Days

Class 2

Risk

About This 510(k) Submission

K950287 is an FDA 510(k) clearance for the UNIVIT PROBE, a Instrument, Vitreous Aspiration And Cutting, Battery-powered (Class II — Special Controls, product code HKP), submitted by Medical Instrument Development Laboratories, Inc. (San Leandro, US). The FDA issued a Cleared decision on April 10, 1995, 76 days after receiving the submission on January 24, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number	K950287 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 1995
Decision Date	April 10, 1995
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	HKP — Instrument, Vitreous Aspiration And Cutting, Battery-powered
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.4150