Cleared Traditional

K924901 - DEANS DISPOSABLE T-TUBE INSERTER
(FDA 510(k) Clearance)

K924901 · Exmoor Plastics , Ltd. · Ear, Nose, Throat
Jan 1993
Decision
141d
Days
Class 1
Risk

K924901 is an FDA 510(k) clearance for the DEANS DISPOSABLE T-TUBE INSERTER. This device is classified as a Inserter, Myringotomy Tube (Class I — General Controls, product code JYM).

Submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on January 28, 1993, 141 days after receiving the submission on September 9, 1992.

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

Submission Details

510(k) Number K924901 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1992
Decision Date January 28, 1993
Days to Decision 141 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code JYM — Inserter, Myringotomy Tube
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4420