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510(k) K232658

T-Top 10 & T-Top T-Top 11 by Tuttnauer U.S.A Co, Ltd. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2023
Date Received
August 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 Tuttnauer U.S.A Co, Ltd.

  • K143311 — Pre-vacuum Tabletop Autoclave (January 15, 2015)
  • K090783 — TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE (August 20, 2009)
  • K032192 — PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 (August 12, 2004)
  • K021504 — TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540 (July 25, 2002)
  • K993856 — TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP (February 9, 2001)
  • K990761 — TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE (July 9, 1999)
  • K962282 — TUTTNAUER PREVACUUM TABLE AUTOCLAVE (November 12, 1997)
  • K973550 — TUTTNAUER TABLE-TOP AUTOCLAVE (October 29, 1997)

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)
  • K232485 — AMSCO 600 Steam Sterilizer (September 13, 2023)