Cleared Traditional

K923725 - OPHTHALMIC PHARCO NEEDLE
(FDA 510(k) Clearance)

K923725 · Synergetics, Inc. · Ophthalmic

Mar 1993

Decision

234d

Days

Class 2

Risk

K923725 is an FDA 510(k) clearance for the OPHTHALMIC PHARCO NEEDLE, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Synergetics, Inc. (Chesterfield, US). The FDA issued a Cleared decision on March 18, 1993, 234 days after receiving the submission on July 27, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number	K923725 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 27, 1992
Decision Date	March 18, 1993
Days to Decision	234 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement