Suh Vent Tube
by Boston Medical Products, Inc.
510(k) K910618
Suh Vent Tube is a medical device (FDA Class II; FDA product code ETD, Tube, Tympanostomy) made by Boston Medical Products, Inc., cleared under FDA 510(k) K910618 on 28 Jun 1991, 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 | NumberK910618 | Date28 Jun 1991 | StatusActive |
Official records
- FDA 510(k) database K910618
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- Withdrawn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 70145326 by Gyrus Acmi, Inc.
- 'EXMOOR' T-TUBE by Exmoor Plastics Limited
- GYRUS ACMI 70140280 by Gyrus Acmi, Inc.
- Hummingbird Tympanostomy Tube by Preceptis Medical
- Biowy Tym Tube (TT) by Biowy Corporation
- TYMPANOSTOMY VENTILATION TUBE by Ikonos Corp.
- HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER by MEDTRONIC XOMED, INC.
- SHAH PERMAVENT by Exmoor Plastics Limited
- TYTAN REUTER BOBBIN VENT TUBE by Treace Medical, Inc.
- VENTILATION TUBE TEFLON SHEPARD TYPE by Xomed, Inc.