Panels › Gastroenterology, Urology › Product code GBT · Class 2
Catheter, Rectal
Regulation 876.5980
0510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in GBT
| Company | 510(k)s | Recalls |
|---|---|---|
| Innovatec Medical Corp. | 1 | 0 |
| Medspira, Llc | 0 | 1 |
| Tonometrics, Inc. | 1 | 0 |
| Tri-Med Specialties, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2017 | Medspira, Llc mcompass 2-channel Balloon Catheters
The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-00 Terminated |
GBT | K120088 K143031 |
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