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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2016 | Custom Ultrasonics, Inc. The System 83 Plus, Endoscope Washer/Disinfector
Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. Terminated |
NVE | None listed |
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