Cleared Traditional

UNITED SURGICAL CORP. DIATHERMIC PLUS

K870194 · United Surgical Corp. · Ophthalmic
Feb 1987
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K870194 is an FDA 510(k) clearance for the UNITED SURGICAL CORP. DIATHERMIC PLUS, a Apparatus, Cautery, Radiofrequency, Ac-powered (Class II — Special Controls, product code HQR), submitted by United Surgical Corp. (Irvine, US). The FDA issued a Cleared decision on February 20, 1987, 31 days after receiving the submission on January 20, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4100.

Submission Details

510(k) Number K870194 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 1987
Decision Date February 20, 1987
Days to Decision 31 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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