Reliance Endoscope Processing System
FDA 510(k) K110453 · STERIS Corporation
510(k) numberK110453
Submission
- Device name
- Reliance Endoscope Processing System
- Applicant
- STERIS Corporation
Mentor, OH, US - Received
- February 16, 2011
- Decision date
- March 16, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NZA – Accessories, Germicide, Cleaning, For Endoscopes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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).
Other 510(k)s with product code NZA
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|---|---|---|---|
| K232918 | enspire 300 Series Automated Endoscope ReprocessorNZA · Special | STERIS Corporation | 10/03/2023SE |
| K230560 | enspire 300 Series Automated Endoscope Reprocessor SystemNZA · Traditional | STERIS Corporation | 07/21/2023SE |
| K220361 | Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideNZA · Special | STERIS Corporation | 03/10/2022SE |
| K203223 | Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideNZA · Traditional | Steris | 01/28/2021SE |
| K200989 | Reliance Endoscope Processing SystemNZA · Special | STERIS Corporation | 05/14/2020SE |
| K123768 | Reliance Advance Endoscope Processing SystemNZA · Traditional | STERIS Corporation | 07/26/2013SE |
| K102244 | Reliance Endoscope Processing SystemNZA · Traditional | STERIS Corporation | 12/03/2010SE |
| K040049 | The Reliance Endoscope Processing SystemNZA · Traditional | STERIS Corporation | 12/17/2004SE |
| K860704 | The Keymed Sigmoidoscope Disinfection StandNZA · Traditional | Keymed, Inc. | 06/17/1986SE |
| K841331 | Olympus KC-10 Mobile Disinfec-StatNZA · Traditional | Keymed, Inc. | 07/19/1984SE |
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Questions and answers
When was Reliance Endoscope Processing System cleared by the FDA?
Reliance Endoscope Processing System (K110453) received a 510(k) decision of Substantially Equivalent on March 16, 2011, 28 days after the submission was received.
What is the product code of K110453?
The FDA product code is NZA – Accessories, Germicide, Cleaning, For Endoscopes, a Class II (moderate risk) device regulated under 21 CFR 876.1500.