Ot-1720
Ot-1720, a tympanostomy tube (FDA Class II; FDA product code ETD, Tube, Tympanostomy) made by Summit Medical, LLC, was cleared under FDA 510(k) K991670 on 26 Aug 1999 and listed in FDA GUDID on 24 Sep 2016 (UDI-DI 00385640014618); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00385640014618 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK991670 | Date26 Aug 1999 | StatusActive |
Official records
- AccessGUDID record 00385640014618
- FDA 510(k) database K991670
Across registries
- FDA 510(k) K991670 decided 26 Aug 1999 Active
- FDA GUDID UDI-DI 00385640014618 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K991670
- Listed FDA GUDID 00385640014618
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Tympanostomy tube
- Model / reference
- OT-1720
- Primary DI / UDI-DI
- 00385640014618
- 510(k) Number
- FDA product code
- ETD
- GMDN term
- Tympanostomy tube
- Device class
- Class II
- Regulation number
- 874.3880
- GUDID distribution status
- Not in Commercial Distribution
Similar devices
Other devices filed under FDA product code ETD (Tube, Tympanostomy).
- BIO-VENT REUTER BOBBIN TUBE by Richards Medical Co., Inc.
- Gyrus ACMI 140244-ENT by Gyrus Acmi, Inc.
- SUH VENT TUBE by Boston Medical Products, Inc.
- VENTILATION TUBES W/ HYDROGEL COATING by Microbio-Medics, Inc.
- GYRUS ACMI 70241375 by Gyrus Acmi, Inc.
- Hummingbird Tympanostomy Tube System by Preceptis Medical
- OTOLOGICAL VENTILATION TUBES by Humboldt Products
- TYMPANOSTOMY VENTILATION TUBE by Advanced Microbotics Corp.
- Tula Tympanostomy Tube Delivery Device by Tusker Medical, Inc.
- TYMPANOSTOMY TUBE by Grace Medical, Inc.