Cleared Traditional

REPROCESSED DISPOSABLE TROCARS

K022743 · Medical Device Services · Ear, Nose, Throat

Oct 2002

Decision

51d

Days

Class 1

Risk

About This 510(k) Submission

K022743 is an FDA 510(k) clearance for the REPROCESSED DISPOSABLE TROCARS, a Trocar, Laryngeal (Class I — General Controls, product code KAB), submitted by Medical Device Services (St. George, US). The FDA issued a Cleared decision on October 9, 2002, 51 days after receiving the submission on August 19, 2002. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number	K022743 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 2002
Decision Date	October 09, 2002
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF