Needle BSN2423
Needle BSN2423 is a Class I device made by B& L Biotech, inc., cleared under FDA 510(k) K060347 on 5 Jun 2006 and listed in FDA GUDID since 21 May 2019 (UDI-DI 08800019101536), 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 | Number08800019101536 | Date21 May 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK060347 | Date5 Jun 2006 | StatusActive |
Official records
- AccessGUDID record 08800019101536
- FDA 510(k) database K060347
Across registries
- FDA 510(k) K060347 decided 5 Jun 2006 Active
- FDA GUDID UDI-DI 08800019101536 listed 21 May 2019 Listed
Timeline
- Cleared FDA 510(k) K060347
- Listed FDA GUDID 08800019101536
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Needle
- Generic name
- Endodontic obturation system
- Model / reference
- BSN2423
- Primary DI / UDI-DI
- 08800019101536
- 510(k) Number
- FDA product code
- EKR
- GMDN term
- Endodontic obturation system
- Device class
- Class I
- Regulation number
- 872.4565
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Endodontic obturation system.