Cleared Traditional

K934261 - ERBOKRYO CA CRYOSURGICAL SYSTEM
(FDA 510(k) Clearance)

K934261 · Erbe Elektromedizin GmbH · General & Plastic Surgery

Apr 1994

Decision

238d

Days

Class 2

Risk

K934261 is an FDA 510(k) clearance for the ERBOKRYO CA CRYOSURGICAL SYSTEM, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by Erbe Elektromedizin GmbH (Orange, US). The FDA issued a Cleared decision on April 26, 1994, 238 days after receiving the submission on August 31, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.

Submission Details

510(k) Number	K934261 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 1993
Decision Date	April 26, 1994
Days to Decision	238 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement