Acclarent Navwire GW35150NZ
Acclarent Navwire GW35150NZ is a Class II device made by Acclarent, Inc., cleared under FDA 510(k) K161697 on 24 Oct 2016 and listed in FDA GUDID since 1 Aug 2017 (UDI-DI 10705031237087), active 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 | Number10705031237087 | Date1 Aug 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK161697 | Date24 Oct 2016 | StatusActive |
Official records
- AccessGUDID record 10705031237087
- FDA 510(k) database K161697
Across registries
- FDA 510(k) K161697 decided 24 Oct 2016 Active
- FDA GUDID UDI-DI 10705031237087 listed 1 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K161697
- Listed FDA GUDID 10705031237087
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Acclarent Navwire
- Generic name
- Paranasal sinus guidewire
- Model / Ref / Catalog
- GW35150NZ
- Primary DI / UDI-DI
- 10705031237087
- 510(k) Number
- FDA product code
- PGW
- GMDN term
- Paranasal sinus guidewire
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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