FHX
6 FDA 510(k) clearances · Product code
85 daysmedian time to decision
144 days90th percentile
6clearances measured
FDA profile
- Official device name
- Jelly, Lubricating, For Transurethral Surgical Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2005: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LUBRICANO STERILE GEL (K081990) | Farco Pharma GmbH | 2008-12-05 |
| BUTTON LUBRICATOR (K951713) | Fibertech Instruments, Inc. | 1995-04-25 |
| CATHEJELL S STERILE LUBRICATING JELLY (K935548) | Pharmazeutische Fabrik Montavit GmbH | 1994-03-30 |
| OPERAND LUBRICATING JELLY (K912132) | General Medical Co. | 1991-08-07 |
| K-Y LUBRICATING JELLY (K780386) | Johnson & Johnson Professionals, Inc. | 1978-04-13 |
| LUBE JEL (K771364) | Travenol Laboratories, S.A. | 1977-08-02 |
Track FHX automatically
Every clearance here is in the API, with alerts when new ones post.