Panels › Gastroenterology, Urology › Product code FHX · Class 2
Jelly, Lubricating, For Transurethral Surgical Instrument
Regulation 876.1500
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FHX
| Company | 510(k)s | Recalls |
|---|---|---|
| Farco Pharma GmbH | 1 | 0 |
| Fibertech Instruments, Inc. | 1 | 0 |
| General Medical Co. | 1 | 0 |
| Johnson & Johnson Professionals, Inc. | 1 | 0 |
| Pharmazeutische Fabrik Montavit GmbH | 1 | 0 |
| Travenol Laboratories, S.A. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 5, 2008 | K081990 | LUBRICANO STERILE GEL Farco Pharma GmbH | FHX |
| Apr 25, 1995 | K951713 | BUTTON LUBRICATOR Fibertech Instruments, Inc. | FHX |
| Mar 30, 1994 | K935548 | CATHEJELL S STERILE LUBRICATING JELLY Pharmazeutische Fabrik Montavit GmbH | FHX |
| Aug 7, 1991 | K912132 | OPERAND LUBRICATING JELLY General Medical Co. | FHX |
| Apr 13, 1978 | K780386 | K-Y LUBRICATING JELLY Johnson & Johnson Professionals, Inc. | FHX |
| Aug 2, 1977 | K771364 | LUBE JEL Travenol Laboratories, S.A. | FHX |
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