SpineJet® 58663
SpineJet® 58663 is a Class II device made by Hydrocision, Inc., cleared under FDA 510(k) K002764 on 24 Nov 2000 and listed in FDA GUDID since 21 Aug 2017 (UDI-DI 00853235007180), 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 | GUDID listing | Number00853235007180 | Date21 Aug 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK002764 | Date24 Nov 2000 | StatusActive |
Official records
- AccessGUDID record 00853235007180
- FDA 510(k) database K002764
Across registries
- FDA 510(k) K002764 decided 24 Nov 2000 Active
- FDA GUDID UDI-DI 00853235007180 listed 21 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K002764
- Listed FDA GUDID 00853235007180
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SpineJet®
- Generic name
- Water jet knife system handpiece, single-use
- Model / Ref / Catalog
- 58663
- Description
- SpineJet® 30°XL MIS-Rectangle
- Primary DI / UDI-DI
- 00853235007180
- 510(k) Number
- FDA product code
- HRX
- GMDN term
- Water jet knife system handpiece, single-use
- Device class
- Class II
- Regulation number
- 888.1100
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Water jet knife system handpiece, single-use.