Cleared Traditional

K914086 - ICAN CYLINDRICAL SPONGES
(FDA 510(k) Clearance)

K914086 · Icn Pharmaceuticals, Inc. · General & Plastic Surgery device

Oct 1991

Decision

28d

Days

Class 1

Risk

K914086 is an FDA 510(k) clearance for the ICAN CYLINDRICAL SPONGES. This device is classified as a Scalpel, One-piece (Class I - General Controls, product code GDX).

Submitted by Icn Pharmaceuticals, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on October 9, 1991, 28 days after receiving the submission on September 11, 1991.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K914086 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 11, 1991
Decision Date	October 09, 1991
Days to Decision	28 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement