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510(k) K232918

enspire 300 Series Automated Endoscope Reprocessor by STERIS Corporation — Product Code NZA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2023
Date Received
September 19, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Germicide, Cleaning, For Endoscopes
Device Class
Class II
Regulation Number
876.1500
Review Panel
HO
Submission Type

High level disinfection of reusable, heat-sensitive devices If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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Other clearances for product code NZA

  • K230560 — enspire 300 Series Automated Endoscope Reprocessor System (July 21, 2023)
  • K220361 — Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide (March 10, 2022)
  • K203223 — Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide (January 28, 2021)
  • K200989 — Reliance Endoscope Processing System (May 14, 2020)
  • K123768 — RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM (July 26, 2013)
  • K110453 — RELIANCE ENDOSCOPE PROCESSING SYSTEM (March 16, 2011)
  • K102244 — RELIANCE ENDOSCOPE PROCESSING SYSTEM (December 3, 2010)
  • K040049 — THE RELIANCE ENDOSCOPE PROCESSING SYSTEM (December 17, 2004)
  • K860704 — THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND (June 17, 1986)
  • K841331 — OLYMPUS KC-10 MOBILE DISINFEC-STAT (July 19, 1984)