RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector
FDA 510(k) clearance K203199 · decided 2020-12-01
Clearance details
- K-number
- K203199
- Device name
- RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2020-10-29
- Decision date
- 2020-12-01
- Days to decision
- 33 days
- Clearance type
- Special
- Product code
- NVE
- 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 |
|---|
| AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (K222849) | Steris | 2022-09-30 |
| AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (K222543) | Steris | 2022-08-25 |
| RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector (K200577) | STERIS Corporation | 2020-04-03 |
| RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector (K190081) | STERIS Corporation | 2019-08-21 |
| DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 (K073112) | Intuitive Surgical, Inc. | 2008-08-01 |
| MANZI CLEANER SYSTEM (K043314) | Langford IC Systems, Inc. | 2005-06-20 |
| MODIFICATION TO SYSTEM 83 PLUS (K983017) | Custom Ultrasonics | 1998-09-22 |
| MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT. (K871712) | Machida America, Inc. | 1988-01-14 |
| KEYMED FIBERSCOPE AUTO DISINFECTOR (K861821) | Keymed, Inc. | 1987-02-12 |
| OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES (K862402) | Medivators, Inc. | 1987-02-03 |
| AUTOMATIC ENDOSCOPE (K832458) | American Endoscopy, Inc. | 1983-10-20 |
Recalls involving this device
No recalls on record reference this clearance.