Cleared Traditional

TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE

K932345 · Conmedcorp · General & Plastic Surgery
Apr 1994
Decision
333d
Days
Class 2
Risk

About This 510(k) Submission

K932345 is an FDA 510(k) clearance for the TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE, a Electrosurgical Device (Class II — Special Controls, product code DWG), submitted by Conmedcorp (Utica, US). The FDA issued a Cleared decision on April 12, 1994, 333 days after receiving the submission on May 14, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K932345 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 1993
Decision Date April 12, 1994
Days to Decision 333 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code DWG — Electrosurgical Device
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4400