Cleared Traditional

GM SWIVEL VIDEO (TM) IRRIGATOR

K931398 · Gm Engineering, Inc. · Ear, Nose, Throat

Aug 1993

Decision

164d

Days

Class 1

Risk

About This 510(k) Submission

K931398 is an FDA 510(k) clearance for the GM SWIVEL VIDEO (TM) IRRIGATOR, a Irrigator, Sinus (Class I — General Controls, product code KAR), submitted by Gm Engineering, Inc. (La Verne, US). The FDA issued a Cleared decision on August 30, 1993, 164 days after receiving the submission on March 19, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number	K931398 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 19, 1993
Decision Date	August 30, 1993
Days to Decision	164 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement