Cleared Traditional

THE GRIESHABER AXIAL CUTTER

K950056 · Grieshaber & Co. · Ophthalmic

May 1995

Decision

119d

Days

Class 2

Risk

About This 510(k) Submission

K950056 is an FDA 510(k) clearance for the THE GRIESHABER AXIAL CUTTER, a Instrument, Vitreous Aspiration And Cutting, Battery-powered (Class II — Special Controls, product code HKP), submitted by Grieshaber & Co. (Kennesaw, US). The FDA issued a Cleared decision on May 5, 1995, 119 days after receiving the submission on January 6, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number	K950056 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 06, 1995
Decision Date	May 05, 1995
Days to Decision	119 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement

Device Classification

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