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Amsco Evolution Medium Steam Sterilizer

by Steris Corporation 4 variants

510(k) K173485

Amsco Evolution Medium Steam Sterilizer is a Class II device made by Steris Corporation, cleared under FDA 510(k) K173485 on 22 Feb 2018, 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 NumberK173485 Date22 Feb 2018ClearedStatusActive

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  • Withdrawn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

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

Devices cleared under K173485

4 devices · 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 K173485
UDI-DISize and differences
Amsco Evolution HC-1500
Steris Mexico, S. de R.L. de C.V.
UE03 / HC-150000724995151539 —On the market
Amsco Evolution HC-1500
Steris Mexico, S. de R.L. de C.V.
UE06 / HC-150000724995151522 —On the market
Amsco Evolution HC-600
Steris Mexico, S. de R.L. de C.V.
UE21 / HC-60000724995151591 —On the market
Amsco Evolution HC-600
Steris Mexico, S. de R.L. de C.V.
UE24 / HC-60000724995151584 —On the market

Similar devices

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

Other devices from Steris Corporation

See all devices from Steris Corporation →