Cleared Traditional

K903302 - ELECTRODE, ELECTROSURGERY (FDA 510(k) Clearance)

Oct 1990
Decision
70d
Days
Class 2
Risk

K903302 is an FDA 510(k) clearance for the ELECTRODE, ELECTROSURGERY. This device is classified as a Electrode, Electrosurgical (Class II - Special Controls, product code JOS).

Submitted by Megadyne Medical Products, Inc. (Murray, US). The FDA issued a Cleared decision on October 2, 1990, 70 days after receiving the submission on July 24, 1990.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K903302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1990
Decision Date October 02, 1990
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code JOS — Electrode, Electrosurgical
Device Class Class II - Special Controls
CFR Regulation 21 CFR 878.4400