Panels › Gastroenterology, Urology › Product code FGM · Class 1
Probe And Director, Gastro-Urology
Regulation 876.4730
0510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in FGM
| Company | 510(k)s | Recalls |
|---|---|---|
| Regulatory & Marketing Services, Inc. | 3 | 0 |
| Blue Torch Medical Technologies | 2 | 0 |
| Uromed Corp. | 2 | 0 |
| Medtronic Gastroenterology / Urology | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 21, 2004 | K041732 | CAVERMAP SURGICAL AID Blue Torch Medical Technologies | FGM |
| Jun 5, 2003 | K031527 | MODIFICATION TO CAVERMAP SURGICAL AID Blue Torch Medical Technologies | FGM |
| Feb 1, 2001 | K010098 | MODIFICATION TO CAVERMAP SURGICAL AID Uromed Corp. | FGM |
| Feb 11, 2000 | K993436 | CAVERMAP SURGICAL AID Uromed Corp. | FGM |
| Feb 15, 1995 | K944384 | ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG Regulatory & Marketing Services, Inc. | FGM |
| Feb 15, 1995 | K944379 | ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG Regulatory & Marketing Services, Inc. | FGM |
| Feb 15, 1995 | K944378 | ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG Regulatory & Marketing Services, Inc. | FGM |
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