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Enbio S

by Enbio Group AG 2 variants

510(k) K210279

Enbio S is a medical device (FDA Class II; FDA product code FLE, Sterilizer, Steam) made by Enbio Group AG, cleared under FDA 510(k) K210279 on 29 Oct 2021, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK210279 Date29 Oct 2021ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K210279

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K210279
UDI-DISize and differences
Enbio S ver. Beauty
Enbio Group AG
Enbio S ver. Beauty07629999932531 —On the market

Similar devices

Other devices filed under FDA product code FLE (Sterilizer, Steam).

Other devices from Enbio Group AG

See all devices from Enbio Group AG →