Acu-Guard 0ADG52
Acu-Guard 0ADG52 is a Class II device made by Acuderm, Inc., cleared under FDA 510(k) K915000 on 27 Jan 1992 and listed in FDA GUDID since 3 Jan 2020 (UDI-DI 00814105020869), 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 | Number00814105020869 | Date3 Jan 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK915000 | Date27 Jan 1992 | StatusActive |
Official records
- AccessGUDID record 00814105020869
- FDA 510(k) database K915000
Across registries
- FDA 510(k) K915000 decided 27 Jan 1992 Active
- FDA GUDID UDI-DI 00814105020869 listed 3 Jan 2020 Listed
Timeline
- Cleared FDA 510(k) K915000
- Listed FDA GUDID 00814105020869
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Acu-Guard
- Generic name
- Medical equipment drape, single-use, non-sterile
- Model / reference
- 0ADG52
- Primary DI / UDI-DI
- 00814105020869
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Medical equipment drape, single-use, non-sterile
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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