FDA product code FFQ: Speculum, Rectal
FFQ is the FDA product code for speculum, rectal. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FFQ. The average 510(k) review took 28 days (median 28).
Classification
| Field | Value |
|---|---|
| Device name | Speculum, Rectal |
| Device class | Class I |
| Regulation | 21 CFR 876.4730 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Top FFQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Artiberia | 1 | 1985-05-23 |
Most recent FFQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851797 | Artiberia | 53-100 TO 53-120 VARIOUS RECTAL SPECULA(SIMS, MATH | 1985-05-23 | 28 |
Recalls for FFQ devices
openFDA lists no recalls for product code FFQ.
Frequently asked questions
What is FDA product code FFQ?
FFQ is the FDA product code for speculum, rectal. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel.
What device class is FFQ?
Class I, regulation 21 CFR 876.4730. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FFQ?
Across 1 cleared submissions the average was 28 days from receipt to decision (median 28).
Which companies have the most FFQ clearances?
Artiberia (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FFQ
- Run a recall and safety report across every FFQ manufacturer
- Watch product code FFQ 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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