Cleared Traditional

ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR

K895800 · Advanced Surgical Products, Inc. · Ophthalmic
Jan 1990
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K895800 is an FDA 510(k) clearance for the ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR, a Apparatus, Cautery, Radiofrequency, Ac-powered (Class II — Special Controls, product code HQR), submitted by Advanced Surgical Products, Inc. (Chesterfield, US). The FDA issued a Cleared decision on January 22, 1990, 116 days after receiving the submission on September 28, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4100.

Submission Details

510(k) Number K895800 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 1989
Decision Date January 22, 1990
Days to Decision 116 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

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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