T-Tube Inserter

FDA 510(k) K870978 · Sur-Med Instruments, Inc.

Substantially Equivalent

510(k) numberK870978

Submission

Device name
T-Tube Inserter
Applicant
Sur-Med Instruments, Inc.
St. Louis, MO, US
Received
March 10, 1987
Decision date
March 19, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JYM – Inserter, Myringotomy Tube
Device class
Class I (low risk)
Regulation
21 CFR 874.4420
Specialty
Ear, Nose, Throat

Other 510(k)s with product code JYM

510(k)DeviceApplicantDecision
K924901Deans Disposable T-Tube InserterJYM · Traditional Exmoor Plastics , Ltd.01/28/1993SE
K822349Armstrong V Tube Suction InserterJYM · Traditional Treace Medical, Inc.09/13/1982SE
K822348Tytan Tube InserterJYM · Traditional Treace Medical, Inc.09/07/1982SE

More from Treace Medical, Inc.

510(k)DeviceDecision
K903401Special RongeurHAE · Traditional 08/10/1990SE
K870897Kodner Anal Perioneal RetractorFFO · Traditional 06/04/1987SE

Questions and answers

When was T-Tube Inserter cleared by the FDA?

T-Tube Inserter (K870978) received a 510(k) decision of Substantially Equivalent on March 19, 1987, 9 days after the submission was received.

What is the product code of K870978?

The FDA product code is JYM – Inserter, Myringotomy Tube, a Class I (low risk) device regulated under 21 CFR 874.4420.