Cleared Traditional

TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U

K093079 · Hobbs Medical, Inc. · Gastroenterology & Urology

Aug 2010

Decision

306d

Days

Class 2

Risk

About This 510(k) Submission

K093079 is an FDA 510(k) clearance for the TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U, a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II — Special Controls, product code KNS), submitted by Hobbs Medical, Inc. (Stafford Springs, US). The FDA issued a Cleared decision on August 2, 2010, 306 days after receiving the submission on September 30, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number	K093079 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2009
Decision Date	August 02, 2010
Days to Decision	306 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement

Device Classification

Product Code	KNS — Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.4300