Cleared Traditional

DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE

K912129 · Biosearch Medical Products, Inc. · Gastroenterology & Urology
Aug 1991
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K912129 is an FDA 510(k) clearance for the DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE, 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 August 7, 1991, 85 days after receiving the submission on May 14, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K912129 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 1991
Decision Date August 07, 1991
Days to Decision 85 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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