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510(k) K213758

Lexa PLUS RIS-311 by W&H Sterilization S.R.L. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2022
Date Received
November 30, 2021
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.

  • K233504 — Lexa MINI (RIS-303, RIS-305) (February 8, 2024)
  • K223858 — Lexa MINI (RIS-303, RIS-305) (May 5, 2023)
  • K172825 — MN-111 (May 30, 2018)

Other clearances for product code FLE

  • K260254 — Enbio PRO (February 26, 2026)
  • K252307 — Getinge GSS67N Series Steam Sterilizer (January 22, 2026)
  • K250168 — Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer (December 30, 2025)
  • K250164 — Cassette Autoclave (ACA5) (August 14, 2025)
  • 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)
  • K233504 — Lexa MINI (RIS-303, RIS-305) (February 8, 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)