FDA product code FHX: Jelly, Lubricating, For Transurethral Surgical Instrument
FHX is the FDA product code for jelly, lubricating, for transurethral surgical instrument. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 6 510(k) submissions under FHX, from 6 different applicants. The average 510(k) review took 69 days (median 60).
Classification
| Field | Value |
|---|---|
| Device name | Jelly, Lubricating, For Transurethral Surgical Instrument |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FHX clearance
Top FHX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Farco Pharma GmbH | 1 | 2008-12-05 |
| Fibertech Instruments, Inc. | 1 | 1995-04-25 |
| Pharmazeutische Fabrik Montavit GmbH | 1 | 1994-03-30 |
| General Medical Co. | 1 | 1991-08-07 |
| Johnson & Johnson Professionals, Inc. | 1 | 1978-04-13 |
1 more applicants have FHX clearances. See the full list in Caduvo.
Most recent FHX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K081990 | Farco Pharma GmbH | LUBRICANO STERILE GEL | 2008-12-05 | 144 |
| K951713 | Fibertech Instruments, Inc. | BUTTON LUBRICATOR | 1995-04-25 | 11 |
| K935548 | Pharmazeutische Fabrik Montavit GmbH | CATHEJELL S STERILE LUBRICATING JELLY | 1994-03-30 | 133 |
| K912132 | General Medical Co. | OPERAND LUBRICATING JELLY | 1991-08-07 | 85 |
| K780386 | Johnson & Johnson Professionals, Inc. | K-Y LUBRICATING JELLY | 1978-04-13 | 34 |
Recalls for FHX devices
openFDA lists no recalls for product code FHX.
Frequently asked questions
What is FDA product code FHX?
FHX is the FDA product code for jelly, lubricating, for transurethral surgical instrument. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FHX?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FHX?
Across 6 cleared submissions the average was 69 days from receipt to decision (median 60).
Which companies have the most FHX clearances?
Farco Pharma GmbH (1); Fibertech Instruments, Inc. (1); Pharmazeutische Fabrik Montavit GmbH (1); General Medical Co. (1); Johnson & Johnson Professionals, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FHX
- Run a recall and safety report across every FHX manufacturer
- Watch product code FHX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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