Panels › Gastroenterology, Urology › Product code FAM · Class 2
Sigmoidoscope And Accessories, Flexible/Rigid
Regulation 876.1500
0510(k)s in 12 months (24 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in FAM
| Company | 510(k)s | Recalls |
|---|---|---|
| Pentax Precision Instrument Corp. | 6 | 0 |
| Vision-Sciences, Inc. | 5 | 0 |
| Welch Allyn, Inc. | 4 | 0 |
| American Optical Corp. | 2 | 0 |
| Pentax Medical Company | 0 | 2 |
| Akos Biomedical, Inc. | 1 | 0 |
| Dynatech Cryomedical Co. | 1 | 0 |
| Harvard Laboratories | 1 | 0 |
| Icl Scientific | 1 | 0 |
| Schott Fiber Optics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2016 | Pentax Medical Company Signmoidoscope
Product Usage:
Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissue Terminated |
FAM | K951572 |
| Jun 28, 2016 | Pentax Medical Company Signmoidoscope
Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystem Terminated |
FAM | K951572 K951577 |
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