Cleared Traditional

K871745 - MODEL 26021C BIPOLAR COAGULATOR (FDA 510(k) Clearance)

K871745 · KARL STORZ Endoscopy-America, Inc. · Obstetrics & Gynecology device

Jul 1987

Decision

66d

Days

Class 2

Risk

K871745 is an FDA 510(k) clearance for the MODEL 26021C BIPOLAR COAGULATOR. This device is classified as a Coagulator-cutter, Endoscopic, Bipolar (and Accessories) (Class II - Special Controls, product code HIN).

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on July 10, 1987, 66 days after receiving the submission on May 5, 1987.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4150.

Submission Details

510(k) Number	K871745 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 05, 1987
Decision Date	July 10, 1987
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—

Device Classification

Product Code	HIN — Coagulator-cutter, Endoscopic, Bipolar (and Accessories)
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 884.4150