Enbio PRO
510(k) K260254
Enbio PRO is a medical device (FDA Class II; FDA product code FLE, Sterilizer, Steam) made by Enbio Group AG, cleared under FDA 510(k) K260254 on 26 Feb 2026, 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 | FDA 510(k)SESE | NumberK260254 | Date26 Feb 2026 | StatusActive |
Official records
- FDA 510(k) database K260254
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FLE
- Device class
- Class II
- Regulation
- 21 CFR Part 880.6880
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
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