Aesculap US513SU
Aesculap US513SU is a Class II device made by Aesculap, Inc., cleared under FDA 510(k) K900533 on 9 Apr 1990 and listed in FDA GUDID since 10 Aug 2020 (UDI-DI 04046955281398), 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 | Number04046955281398 | Date10 Aug 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK900533 | Date9 Apr 1990 | StatusActive |
Official records
- AccessGUDID record 04046955281398
- FDA 510(k) database K900533
Across registries
- FDA 510(k) K900533 decided 9 Apr 1990 Active
- FDA GUDID UDI-DI 04046955281398 listed 10 Aug 2020 Listed
Timeline
- Cleared FDA 510(k) K900533
- Listed FDA GUDID 04046955281398
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aesculap
- Generic name
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
- Model / Ref / Catalog
- US513SU
- Primary DI / UDI-DI
- 04046955281398
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution