Cleared Traditional

GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300

K853291 · Bio-Detek, Inc. · General & Plastic Surgery
Oct 1985
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K853291 is an FDA 510(k) clearance for the GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300, a Apparatus, Electrosurgical (Class II — Special Controls, product code HAM), submitted by Bio-Detek, Inc. (Mansfield, US). The FDA issued a Cleared decision on October 10, 1985, 66 days after receiving the submission on August 5, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K853291 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 1985
Decision Date October 10, 1985
Days to Decision 66 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code HAM — Apparatus, Electrosurgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4400

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