Panels › Gastroenterology, Urology › Product code NVE · Class 2
Washer, Cleaner, Automated, Endoscope
Regulation 876.1500
0510(k)s in 12 months (12 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in NVE
| Company | 510(k)s | Recalls |
|---|---|---|
| STERIS Corporation | 5 | 0 |
| Custom Ultrasonics | 1 | 1 |
| American Endoscopy, Inc. | 1 | 0 |
| Intuitive Surgical, Inc. | 1 | 0 |
| Keymed, Inc. | 1 | 0 |
| Langford IC Systems, Inc. | 1 | 0 |
| Machida America, Inc. | 1 | 0 |
| Medivators, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 30, 2022 | K222849 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization Sy Steris | NVE |
| Aug 25, 2022 | K222543 | AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization S Steris | NVE |
| Dec 1, 2020 | K203199 | RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector STERIS Corporation | NVE |
| Apr 3, 2020 | K200577 | RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector STERIS Corporation | NVE |
| Aug 21, 2019 | K190081 | RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector STERIS Corporation | NVE |
| Aug 1, 2008 | K073112 | DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 Intuitive Surgical, Inc. | NVE |
| Jun 20, 2005 | K043314 | MANZI CLEANER SYSTEM Langford IC Systems, Inc. | NVE |
| Sep 22, 1998 | K983017 | MODIFICATION TO SYSTEM 83 PLUS Custom Ultrasonics | NVE |
| Jan 14, 1988 | K871712 | MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT. Machida America, Inc. | NVE |
| Feb 12, 1987 | K861821 | KEYMED FIBERSCOPE AUTO DISINFECTOR Keymed, Inc., GB | NVE |
| Feb 3, 1987 | K862402 | OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES Medivators, Inc. | NVE |
| Oct 20, 1983 | K832458 | AUTOMATIC ENDOSCOPE American Endoscopy, Inc. | NVE |
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