RELIANCE ENDOSCOPE PROCESSING SYSTEM
FDA 510(k) clearance K110453 · decided 2011-03-16
Clearance details
- K-number
- K110453
- Device name
- RELIANCE ENDOSCOPE PROCESSING SYSTEM
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2011-02-16
- Decision date
- 2011-03-16
- Days to decision
- 28 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
+ Add to Predicate Builder ◉ Watch STERIS Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 Endoscope Processing System (K200989) | STERIS Corporation | 2020-05-14 |
| RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM (K123768) | STERIS Corporation | 2013-07-26 |
| 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
| Record | Firm | Date |
|---|---|---|
| Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor recall (Z-2263-2013) | Steris Corporation | 2013-09-20 |