Cleared Traditional

STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)

K952151 · Storz · Ophthalmic
Mar 1996
Decision
301d
Days
Class 2
Risk

About This 510(k) Submission

K952151 is an FDA 510(k) clearance for the STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204), a Apparatus, Cautery, Radiofrequency, Ac-powered (Class II — Special Controls, product code HQR), submitted by Storz (St. Louis, US). The FDA issued a Cleared decision on March 4, 1996, 301 days after receiving the submission on May 8, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4100.

Submission Details

510(k) Number K952151 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 1995
Decision Date March 04, 1996
Days to Decision 301 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQR — Apparatus, Cautery, Radiofrequency, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4100

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