Exodus 10528
Exodus 10528 is a Class II device made by Navilyst Medical, Inc., cleared under FDA 510(k) K152069 on 24 Sep 2015 and listed in FDA GUDID since 3 Aug 2016 (UDI-DI H965105280), 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 | NumberH965105280 | Date3 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152069 | Date24 Sep 2015 | StatusActive |
Official records
- FDA 510(k) database K152069
Across registries
- FDA 510(k) K152069 decided 24 Sep 2015 Active
- FDA GUDID UDI-DI H965105280 listed 3 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K152069
- Listed FDA GUDID H965105280
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Exodus
- Generic name
- Biliary drain
- Model / reference
- 10528
- Primary DI / UDI-DI
- H965105280
- 510(k) Number
- FDA product code
- FGE
- GMDN term
- Biliary drain
- Device class
- Class II
- Regulation number
- 876.5010
- GUDID distribution status
- In Commercial Distribution
- Size
- Catheter Gauge — 14 FrenchLength — 35 CentimeterOuter Diameter — 4.7 Millimeter
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