TSH Ria

FDA 510(k) K833910 · Syncor Intl. Corp.

Substantially Equivalent

510(k) numberK833910

Submission

Device name
TSH Ria
Applicant
Syncor Intl. Corp.
Mchenry, IL, US
Received
November 14, 1983
Decision date
November 22, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ETD – Tube, Tympanostomy
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3880
Specialty
Ear, Nose, Throat
Implant
Yes

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K232702Solo+ Tympanostomy Tube Device (TTD)ETD · Traditional Aventamed Dac05/20/2024SE
K233658Biowy Tym Tube (TT)ETD · Traditional Biowy Corporation02/16/2024SE
K232059Tympanostomy TubesETD · Traditional Grace Medical, Inc.11/24/2023SE
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K171239TULA Tube Delivery SystemETD · Special Tusker Medical06/28/2017SE
K151830Hummingbird Tympanostomy TubeETD · Traditional Preceptis Medical09/21/2015SE
K151067Ventilation (Tympanostomy) TubesETD · Traditional Medtronic Xomed, Inc.07/22/2015SE

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K850433Cesium 137 Endometrial SourceKXK · Traditional 08/21/1985SE
K852665Syncor Trich Direct Immunofluorescence AssayJWZ · Traditional 08/13/1985SE
K851033Syncortech Chlamydia Direct Speciman KitLJP · Traditional 06/21/1985SE
K844735Pth-RiaCEW · Traditional 04/29/1985SE
K850726Wire Cutters, Brachytherapy-Table Top & Hand HeldIWA · Traditional 03/26/1985SE
K850434CS137 Sealed SourcesKXK · Traditional 03/26/1985SE
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Questions and answers

When was TSH Ria cleared by the FDA?

TSH Ria (K833910) received a 510(k) decision of Substantially Equivalent on November 22, 1983, 8 days after the submission was received.

What is the product code of K833910?

The FDA product code is ETD – Tube, Tympanostomy, a Class II (moderate risk) device regulated under 21 CFR 874.3880.