FDA product code FFZ: Cord, Electric, For Endoscope
FFZ is the FDA product code for cord, electric, for endoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under FFZ, from 3 different applicants. The average 510(k) review took 102 days (median 33). FDA has posted 1 recall for FFZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Cord, Electric, For Endoscope |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every FFZ clearance
Top FFZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sandhill Scientific, Inc. | 1 | 2011-12-19 |
| Kelleher Corp. | 1 | 1982-08-20 |
| Concept, Inc. | 1 | 1979-01-10 |
Most recent FFZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K111013 | Sandhill Scientific, Inc. | ACEM | 2011-12-19 | 252 |
| K822254 | Kelleher Corp. | ELECTRIC CORD FOR ENDOSCOPE | 1982-08-20 | 22 |
| K782046 | Concept, Inc. | C-CORD | 1979-01-10 | 33 |
Recalls for FFZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2001-01-25.
Frequently asked questions
What is FDA product code FFZ?
FFZ is the FDA product code for cord, electric, for endoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FFZ?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FFZ?
Across 3 cleared submissions the average was 102 days from receipt to decision (median 33).
Which companies have the most FFZ clearances?
Sandhill Scientific, Inc. (1); Kelleher Corp. (1); Concept, Inc. (1).
Have FFZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2001-01-25.
Next steps
- Run an FDA pathway report with predicate devices for product code FFZ
- Run a recall and safety report across every FFZ manufacturer
- Watch product code FFZ 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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