Silverstein Microwick
510(k) K991670
Silverstein Microwick is a medical device (FDA Class II; FDA product code ETD, Tube, Tympanostomy) made by Micromedics, Inc., cleared under FDA 510(k) K991670 on 26 Aug 1999, 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 | NumberK991670 | Date26 Aug 1999 | StatusActive |
Official records
- FDA 510(k) database K991670
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- Withdrawn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
Devices cleared under K991670
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| OT-1700 | OT-1700 | 00385640014601 | — | On the market |
| OT-1720 | OT-1720 | 00385640014618 | — | No longer on the market |
Similar devices
Other devices filed under FDA product code ETD (Tube, Tympanostomy).
- Gyrus ACMI 140248-ENT by Gyrus Acmi, Inc.
- TYMPANOSTOMY VENTILATION TUBE by Ikonos Corp.
- HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER by MEDTRONIC XOMED, INC.
- Gyrus ACMI 70145060 by Gyrus Acmi, Inc.
- SHAH PERMAVENT by Exmoor Plastics Limited
- TYTAN REUTER BOBBIN VENT TUBE by Treace Medical, Inc.
- VENTILATION TUBE TEFLON SHEPARD TYPE by Xomed, Inc.
- TITANIUM VENTILATION TUBES by Exmoor Plastics Limited
- SILICONE TYMPANOSTOMY TUBES by Smith & Nephew Richards, Inc.
- AT2 & DOYLE STYLE (C-FLEX) VENT TUBES by Trebay Medical Corp.