Cleared Traditional

WEISS RETINAL CANNULA

K010305 · Micron Surgical, Inc. · Ophthalmic

May 2001

Decision

90d

Days

Class 1

Risk

About This 510(k) Submission

K010305 is an FDA 510(k) clearance for the WEISS RETINAL CANNULA, a Cannula, Ophthalmic (Class I — General Controls, product code HMX), submitted by Micron Surgical, Inc. (Margate, US). The FDA issued a Cleared decision on May 2, 2001, 90 days after receiving the submission on February 1, 2001. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number	K010305 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2001
Decision Date	May 02, 2001
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF