Surgical Direct SD491428-00
Surgical Direct SD491428-00 is a Class II device made by Surgical Direct, Inc., cleared under FDA 510(k) K031972 on 15 Sep 2003 and listed in FDA GUDID since 30 Nov 2022 (UDI-DI B382SD491428000), 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 | NumberB382SD491428000 | Date30 Nov 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK031972 | Date15 Sep 2003 | StatusActive |
Official records
- FDA 510(k) database K031972
Across registries
- FDA 510(k) K031972 decided 15 Sep 2003 Active
- FDA GUDID UDI-DI B382SD491428000 listed 30 Nov 2022 Listed
Timeline
- Cleared FDA 510(k) K031972
- Listed FDA GUDID B382SD491428000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Surgical Direct
- Generic name
- Endoscope sheath, reusable
- Model / Ref / Catalog
- SD491428-00
- Primary DI / UDI-DI
- B382SD491428000
- 510(k) Number
- FDA product code
- HRX
- GMDN term
- Endoscope sheath, reusable
- Device class
- Class II
- Regulation number
- 888.1100
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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