Sp-30250
Sp-30250 is an instrument/equipment drape (FDA Class II; FDA product code CAF, Nebulizer (Direct Patient Interface)) made by Summit Medical, LLC, cleared under FDA 510(k) K911785 on 7 Oct 1991 and listed in FDA GUDID since 5 Oct 2016 (UDI-DI 00385640000086), 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 | Number00385640000086 | Date5 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK911785 | Date7 Oct 1991 | StatusActive |
Official records
- AccessGUDID record 00385640000086
- FDA 510(k) database K911785
Across registries
- FDA 510(k) K911785 decided 7 Oct 1991 Active
- FDA GUDID UDI-DI 00385640000086 listed 5 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K911785
- Listed FDA GUDID 00385640000086
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Instrument/equipment drape, single-use, non-sterile
- Model / reference
- SP-30250
- Primary DI / UDI-DI
- 00385640000086
- 510(k) Number
- FDA product code
- CAF
- GMDN term
- Instrument/equipment drape, single-use, non-sterile
- Device class
- Class II
- Regulation number
- 868.5630
- GUDID distribution status
- In Commercial Distribution
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