Compass International SP-20
Compass International SP-20 is a Class II device made by Compass International, listed in FDA GUDID since 26 Aug 2016 (UDI-DI B169SP200), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB169SP200 | Date26 Aug 2016 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Compass International
- Generic name
- Neurological stereotactic surgery system
- Model / Ref / Catalog
- SP-20
- Primary DI / UDI-DI
- B169SP200
- FDA product code
- HAW
- GMDN term
- Neurological stereotactic surgery system
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Ethylene Oxide
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