THE RELIANCE ENDOSCOPE PROCESSING SYSTEM
FDA 510(k) clearance K040049 · decided 2004-12-17
Clearance details
- K-number
- K040049
- Device name
- THE RELIANCE ENDOSCOPE PROCESSING SYSTEM
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2004-01-12
- Decision date
- 2004-12-17
- Days to decision
- 340 days
- Clearance type
- Traditional
- 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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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 |
| Steris Reliance EPS Endoscope Processing System , manufactured by Corporation STERIS Canad recall (Z-0823-2011) | Steris Corporation | 2010-12-28 |