Ventilation Tubes W/ Hydrogel Coating
FDA 510(k) K923353 · Microbio-Medics, Inc.
510(k) numberK923353
Submission
- Device name
- Ventilation Tubes W/ Hydrogel Coating
- Applicant
- Microbio-Medics, Inc.
Memphis, TN, US - Received
- July 8, 1992
- Decision date
- May 18, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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|---|---|---|---|
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| K233658 | Biowy Tym Tube (TT)ETD · Traditional | Biowy Corporation | 02/16/2024SE |
| K232059 | Tympanostomy TubesETD · Traditional | Grace Medical, Inc. | 11/24/2023SE |
| K221254 | Hummingbird Tympanostomy Tube SystemETD · Traditional | Preceptis Medical, Inc. | 07/27/2022SE |
| K200952 | Hummingbird Tympanostomy Tube SystemETD · Traditional | Preceptis Medical, Inc. | 06/05/2020SE |
| K171239 | TULA Tube Delivery SystemETD · Special | Tusker Medical | 06/28/2017SE |
| K151830 | Hummingbird Tympanostomy TubeETD · Traditional | Preceptis Medical | 09/21/2015SE |
| K151067 | Ventilation (Tympanostomy) TubesETD · Traditional | Medtronic Xomed, Inc. | 07/22/2015SE |
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| K900726 | Microtek Medical's Blood Collection KitJKA · Traditional | 05/04/1990SE |
| K901154 | Microtek's Surgical Lamp Handle & CoverFTA · Traditional | 03/20/1990SE |
| K895815 | Microtek Total Ossicular ProthesisETA · Traditional | 12/26/1989SE |
| K895814 | Microtek Piston & Wire ProsthesesETB · Traditional | 12/26/1989SE |
| K895502 | Microtek Reuter-Style Bi-Valve Intranasal SplintEPP · Traditional | 12/08/1989SE |
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Questions and answers
When was Ventilation Tubes W/ Hydrogel Coating cleared by the FDA?
Ventilation Tubes W/ Hydrogel Coating (K923353) received a 510(k) decision of Substantially Equivalent on May 18, 1993, 314 days after the submission was received.
What is the product code of K923353?
The FDA product code is ETD – Tube, Tympanostomy, a Class II (moderate risk) device regulated under 21 CFR 874.3880.