Cleared Traditional

K953242 - SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES
(FDA 510(k) Clearance)

K953242 · Symbiosis Corp. · Obstetrics & Gynecology

Oct 1995

Decision

87d

Days

Class 2

Risk

K953242 is an FDA 510(k) clearance for the SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES. This device is classified as a Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (Class II — Special Controls, product code KNF).

Submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on October 6, 1995, 87 days after receiving the submission on July 11, 1995.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4160.

Submission Details

510(k) Number	K953242 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 1995
Decision Date	October 06, 1995
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF