Cleared Traditional

K925161 - NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO
(FDA 510(k) Clearance)

K925161 · North American Sterilization & Packaging Co. · Gastroenterology & Urology device

Jul 1993

Decision

281d

Days

Class 2

Risk

K925161 is an FDA 510(k) clearance for the NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO. This device is classified as a Accessories, Catheter, G-u (Class II - Special Controls, product code KNY).

Submitted by North American Sterilization & Packaging Co. (Sparta, US). The FDA issued a Cleared decision on July 21, 1993, 281 days after receiving the submission on October 13, 1992.

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

Submission Details

510(k) Number	K925161 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 13, 1992
Decision Date	July 21, 1993
Days to Decision	281 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement