FHX — Jelly, Lubricating, For Transurethral Surgical Instrument Class II
FDA product code FHX covers "Jelly, Lubricating, For Transurethral Surgical Instrument", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FHX
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K081990 | farco pharma | LUBRICANO STERILE GEL | December 5, 2008 |
| K951713 | fibertech instruments | BUTTON LUBRICATOR | April 25, 1995 |
| K935548 | pharmazeutische fabrik montavit | CATHEJELL S STERILE LUBRICATING JELLY | March 30, 1994 |
| K912132 | general medical | OPERAND LUBRICATING JELLY | August 7, 1991 |
| K780386 | johnson and johnson professionals | K-Y LUBRICATING JELLY | April 13, 1978 |
| K771364 | travenol laboratories | LUBE JEL | August 2, 1977 |