enspire 300 Series Automated Endoscope Reprocessor System
FDA 510(k) K230560 · STERIS Corporation
510(k) numberK230560
Submission
- Device name
- enspire 300 Series Automated Endoscope Reprocessor System
- Applicant
- STERIS Corporation
Mentor, OH, US - Received
- February 28, 2023
- Decision date
- July 21, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232918 | enspire 300 Series Automated Endoscope ReprocessorNZA · Special | STERIS Corporation | 10/03/2023SE |
| 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 |
| K110453 | Reliance Endoscope Processing SystemNZA · Special | STERIS Corporation | 03/16/2011SE |
| 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 |
More from Keymed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261055 | AMSCO 700 Steam SterilizerFLE · Traditional | 06/24/2026SE |
| K260766 | Celerity 5 HP Biological Indicator (LCB052)FRC · Special | 04/08/2026SE |
| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid…MED · Traditional | 04/08/2026SE |
| K252680 | Celerity 20 HP Biological IndicatorFRC · Special | 09/24/2025SE |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | 06/06/2025SE |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118JOJ · Special | 05/02/2025SE |
| K243876 | VERIFY STEAM Integrating IndicatorJOJ · Special | 04/25/2025SE |
| K250842 | PADLOCK CLIP EFTR Kit (00713229)PKL · Special | 04/18/2025SE |
| K242773 | Electro Lube NXTGEI · Traditional | 04/15/2025SE |
| K250061 | Celerity IncubatorFRC · Special | 02/06/2025SE |
Questions and answers
When was enspire 300 Series Automated Endoscope Reprocessor System cleared by the FDA?
enspire 300 Series Automated Endoscope Reprocessor System (K230560) received a 510(k) decision of Substantially Equivalent on July 21, 2023, 143 days after the submission was received.
What is the product code of K230560?
The FDA product code is NZA – Accessories, Germicide, Cleaning, For Endoscopes, a Class II (moderate risk) device regulated under 21 CFR 876.1500.