Cleared Traditional

K921451 - EVACUATOR, GASTRO-UROLOGY
(FDA 510(k) Clearance)

K921451 · Northgate Technologies, Inc. · Gastroenterology & Urology device

Oct 1992

Decision

216d

Days

Class 2

Risk

K921451 is an FDA 510(k) clearance for the EVACUATOR, GASTRO-UROLOGY. This device is classified as a Evacuator, Gastro-urology (Class II - Special Controls, product code KQT).

Submitted by Northgate Technologies, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on October 28, 1992, 216 days after receiving the submission on March 26, 1992.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4370.

Submission Details

510(k) Number	K921451 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 26, 1992
Decision Date	October 28, 1992
Days to Decision	216 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement