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510(k) K233504

Lexa MINI (RIS-303, RIS-305) by W&H Sterilization S.R.L. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2024
Date Received
October 31, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type

Other clearances by W&H Sterilization S.R.L.

  • K223858 — Lexa MINI (RIS-303, RIS-305) (May 5, 2023)
  • K213758 — Lexa PLUS RIS-311 (August 19, 2022)
  • K172825 — MN-111 (May 30, 2018)

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  • K243994 — Steam Sterilizer (2545D) (June 6, 2025)
  • K243801 — FRONT-LINE Field Sterilizer (FL135) (March 7, 2025)
  • K233026 — Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer (April 4, 2024)
  • K233132 — PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) (December 19, 2023)
  • K232658 — T-Top 10 & T-Top T-Top 11 (November 27, 2023)
  • K232485 — AMSCO 600 Steam Sterilizer (September 13, 2023)