Reliance Endoscope Processing System
FDA 510(k) clearance K200989 · decided 2020-05-14
Clearance details
- K-number
- K200989
- Device name
- Reliance Endoscope Processing System
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2020-04-15
- Decision date
- 2020-05-14
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- NZA
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| enspire 300 Series Automated Endoscope Reprocessor (K232918) | STERIS Corporation | 2023-10-03 |
| enspire 300 Series Automated Endoscope Reprocessor System (K230560) | STERIS Corporation | 2023-07-21 |
| Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide (K220361) | STERIS Corporation | 2022-03-10 |
| Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide (K203223) | Steris | 2021-01-28 |
| RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM (K123768) | STERIS Corporation | 2013-07-26 |
| RELIANCE ENDOSCOPE PROCESSING SYSTEM (K110453) | STERIS Corporation | 2011-03-16 |
| RELIANCE ENDOSCOPE PROCESSING SYSTEM (K102244) | STERIS Corporation | 2010-12-03 |
| THE RELIANCE ENDOSCOPE PROCESSING SYSTEM (K040049) | STERIS Corporation | 2004-12-17 |
| THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND (K860704) | Keymed, Inc. | 1986-06-17 |
| OLYMPUS KC-10 MOBILE DISINFEC-STAT (K841331) | Keymed, Inc. | 1984-07-19 |
Recalls involving this device
No recalls on record reference this clearance.