Sinusway Dilation System
510(k) K181838
Sinusway Dilation System is a Class I device made by 3nt Medical, Ltd., cleared under FDA 510(k) K181838 on 20 Dec 2018, active as of 22 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 | NumberK181838 | Date20 Dec 2018 | StatusActive |
Official records
- FDA 510(k) database K181838
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LRC
- FDA applicant
- 3nt Medical , Ltd.
- Device class
- Class I
- Regulation
- 21 CFR Part 874.4420
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code LRC (Instrument, Ent Manual Surgical).
- FENTEX 310101FX by FENTEX medical GmbH
- FENTEX 307909FX by FENTEX medical GmbH
- Cottle nasal rasp 20-820-21 by Spiggle & Theis Medizintechnik GmbH
- Dressing forceps 10-494-12 by Spiggle & Theis Medizintechnik GmbH
- NuVent EM Sinus Dilation System by Medtronic Xomed Inc
- Vent-Os Sinus Dilation family by Sinusys Corporation
- MicroFrance® 7771B by Integra Microfrance
- Provox Capsule 20Fr 7796 by Atos Medical AB
- 745201 by Karl Storz SE & CO. KG
- MicroFrance® MCEN212S by Integra Microfrance