Cleared Traditional

K841951 - MICROSURGICAL KNIFE (FDA 510(k) Clearance)

Jun 1984
Decision
18d
Days
Class 1
Risk

K841951 is an FDA 510(k) clearance for the MICROSURGICAL KNIFE. This device is classified as a Knife, Ophthalmic (Class I - General Controls, product code HNN).

Submitted by Ethicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1984, 18 days after receiving the submission on May 14, 1984.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K841951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1984
Decision Date June 01, 1984
Days to Decision 18 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code HNN — Knife, Ophthalmic
Device Class Class I - General Controls
CFR Regulation 21 CFR 886.4350