Cleared Traditional

K810017 - MICROSURG CAUTERY
(FDA 510(k) Clearance)

Jan 1981
Decision
Days
Class 2
Risk

K810017 is an FDA 510(k) clearance for the MICROSURG CAUTERY. This device is classified as a Unit, Cautery, Thermal, Ac-powered (Class II - Special Controls, product code HQO).

Submitted by Medical Products Development, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1981.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4115.

Submission Details

510(k) Number K810017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received January 05, 1981
Decision Date January 05, 1981
Days to Decision
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code HQO — Unit, Cautery, Thermal, Ac-powered
Device Class Class II - Special Controls
CFR Regulation 21 CFR 886.4115

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