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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 20, 1994 | K941391 | INFLATABLE RETENTION CUFF SPECULUM Innovatec Medical Corp. | GBT |
| Feb 10, 1994 | K924549 | TRI-MED QUICK-STEP(TM) RECTAL TUBE Tri-Med Specialties, Inc. | GBT |
| Apr 21, 1989 | K890466 | SIGMOID TONOMITOR Tonometrics, Inc. | GBT |
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