Cleared Traditional

K822348 - TYTAN TUBE INSERTER
(FDA 510(k) Clearance)

K822348 · Treace Medical, Inc. · Ear, Nose, Throat device

Sep 1982

Decision

32d

Days

Class 1

Risk

K822348 is an FDA 510(k) clearance for the TYTAN TUBE INSERTER. This device is classified as a Inserter, Myringotomy Tube (Class I - General Controls, product code JYM).

Submitted by Treace Medical, Inc. (Walker, US). The FDA issued a Cleared decision on September 7, 1982, 32 days after receiving the submission on August 6, 1982.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number	K822348 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 06, 1982
Decision Date	September 07, 1982
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—