FDA product code FTQ: Prosthesis, Penis, Rigid Rod
FTQ is the FDA product code for prosthesis, penis, rigid rod. It is a Class II device, regulated under 21 CFR 876.3630 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under FTQ, from 2 different applicants. The average 510(k) review took 196 days (median 196).
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Penis, Rigid Rod |
| Device class | Class II |
| Regulation | 21 CFR 876.3630 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every FTQ clearance
Top FTQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Specialty Surgical Products, Inc. | 1 | 1999-02-05 |
| Dacomed Corp. | 1 | 1983-10-20 |
Most recent FTQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K983015 | Specialty Surgical Products, Inc. | VIRILIS PENILE PROSTHESIS | 1999-02-05 | 161 |
| K830667 | Dacomed Corp. | SILICONE-SILVER PENILE PROSTHESIS-ESK | 1983-10-20 | 230 |
Recalls for FTQ devices
openFDA lists no recalls for product code FTQ.
Frequently asked questions
What is FDA product code FTQ?
FTQ is the FDA product code for prosthesis, penis, rigid rod. It is a Class II device, regulated under 21 CFR 876.3630 and reviewed by the Gastroenterology and Urology panel.
What device class is FTQ?
Class II, regulation 21 CFR 876.3630. Typical premarket route: 510(k).
How long does a 510(k) take for product code FTQ?
Across 2 cleared submissions the average was 196 days from receipt to decision (median 196).
Which companies have the most FTQ clearances?
Specialty Surgical Products, Inc. (1); Dacomed Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FTQ
- Run a recall and safety report across every FTQ manufacturer
- Watch product code FTQ 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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