Panels › Gastroenterology, Urology › Product code FEN · Class 2
Device, Cystometric, Hydraulic
Regulation 876.1620
0510(k)s in 12 months (36 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in FEN
| Company | 510(k)s | Recalls |
|---|---|---|
| Fiberoptic Sensor Technlogies, Inc. | 8 | 0 |
| Laborie Medical Technologies, Corp. | 3 | 2 |
| Life-Tech Intl., Inc. | 5 | 0 |
| Medamicus, Inc. | 3 | 0 |
| Rusch Intl. | 2 | 0 |
| Andromeda Medizinische Systeme GmbH | 1 | 0 |
| C.R. Bard, Inc. | 1 | 0 |
| Circon Video | 1 | 0 |
| ConvaTec, Inc | 0 | 1 |
| Cook Urological, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2019 | LABORIE MEDICAL TECHNOLOGIES, CORP U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions Terminated |
FEN | None listed |
| Jul 3, 2018 | ConvaTec, Inc AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301
AbViser is a sterile non-invasive disposable intra- abdominal pressure monitoring dev Terminated |
FEN | None listed |
| Dec 1, 2006 | Laborie Medical Technologies Laborie Transducer Cartridge with Luer Lock
Reference: DIS130 Terminated |
FEN | None listed |
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