Tympovent
510(k) K936275
Tympovent is a medical device (FDA Class II; FDA product code ETD, Tube, Tympanostomy) made by Atos Medical AB, cleared under FDA 510(k) K936275 on 5 May 1994, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK936275 | Date5 May 1994 | StatusActive |
Official records
- FDA 510(k) database K936275
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ETD
- Device class
- Class II
- Regulation
- 21 CFR Part 874.3880
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code ETD (Tube, Tympanostomy).
- Gyrus ACMI 240052 by Gyrus Acmi, Inc.
- GYRUS ACMI 145271-ENT by Gyrus Acmi, Inc.
- PAPARELL TYPE 2, BIOLITE COATED SILI- by Xomed, Inc.
- SOILEAU TYTAN BOBBIN VENT TUBE by Treace Medical, Inc.
- PRO-000-410 by Summit Medical, LLC
- BIO-VENT REUTER BOBBIN TUBE by Richards Medical Co., Inc.
- SUH VENT TUBE by Boston Medical Products, Inc.
- VENTILATION TUBES W/ HYDROGEL COATING by Microbio-Medics, Inc.
- Hummingbird Tympanostomy Tube System by Preceptis Medical
- OTOLOGICAL VENTILATION TUBES by Humboldt Products