Cleared Traditional

DOBBHOFF BIPOLAR ADAPTER

K921029 · Biosearch Medical Products, Inc. · Gastroenterology & Urology
May 1992
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K921029 is an FDA 510(k) clearance for the DOBBHOFF BIPOLAR ADAPTER, a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II — Special Controls, product code KNS), submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on May 6, 1992, 64 days after receiving the submission on March 3, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K921029 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1992
Decision Date May 06, 1992
Days to Decision 64 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

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