Cleared Traditional

PRIZM KERATOME BLADE, MODEL MK8512M2

K033236 · Surgin Surgical Instrumentation, Inc. · Ophthalmic
Mar 2004
Decision
172d
Days
Class 1
Risk

About This 510(k) Submission

K033236 is an FDA 510(k) clearance for the PRIZM KERATOME BLADE, MODEL MK8512M2, a Keratome, Ac-powered (Class I — General Controls, product code HNO), submitted by Surgin Surgical Instrumentation, Inc. (Tustin, US). The FDA issued a Cleared decision on March 26, 2004, 172 days after receiving the submission on October 6, 2003. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4370.

Submission Details

510(k) Number K033236 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 2003
Decision Date March 26, 2004
Days to Decision 172 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HNO — Keratome, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4370

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