Cleared Traditional

K943835 - PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID
(FDA 510(k) Clearance)

K943835 · Orion Life Systems, Inc. · Gastroenterology & Urology device

Jan 1995

Decision

172d

Days

Class 2

Risk

K943835 is an FDA 510(k) clearance for the PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID. This device is classified as a Accessories, Catheter, G-u (Class II - Special Controls, product code KNY).

Submitted by Orion Life Systems, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on January 24, 1995, 172 days after receiving the submission on August 5, 1994.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number	K943835 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 05, 1994
Decision Date	January 24, 1995
Days to Decision	172 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement