FDA product code FFO: Retractor, Self-Retaining
FFO is the FDA product code for retractor, self-retaining. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under FFO, from 4 different applicants. The average 510(k) review took 87 days (median 79). FDA has posted 3 recalls for FFO devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Retractor, Self-Retaining |
| Device class | Class I |
| Regulation | 21 CFR 876.4730 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FFO clearance
Top FFO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dantec Electronics, Inc. | 2 | 1986-04-23 |
| Advanced Surgical Concepts (Asc) | 1 | 1999-12-22 |
| Sur-Med Instruments, Inc. | 1 | 1987-06-04 |
| The Kendal Co. | 1 | 1985-09-20 |
Most recent FFO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K993544 | Advanced Surgical Concepts (Asc) | SPACE-OR RETRACTOR | 1999-12-22 | 64 |
| K870897 | Sur-Med Instruments, Inc. | KODNER ANAL PERIONEAL RETRACTOR | 1987-06-04 | 91 |
| K860368 | Dantec Electronics, Inc. | URDYN 5000 (UROFLOWMETER) | 1986-04-23 | 79 |
| K853119 | Dantec Electronics, Inc. | URODYN 1000 | 1985-10-04 | 71 |
| K852083 | The Kendal Co. | THE KENDALL URINARY OUTPUT MONITOR | 1985-09-20 | 130 |
Recalls for FFO devices
3 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-12-03.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code FFO?
FFO is the FDA product code for retractor, self-retaining. It is a Class I device, regulated under 21 CFR 876.4730 and reviewed by the Gastroenterology and Urology panel.
What device class is FFO?
Class I, regulation 21 CFR 876.4730. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FFO?
Across 5 cleared submissions the average was 87 days from receipt to decision (median 79).
Which companies have the most FFO clearances?
Dantec Electronics, Inc. (2); Advanced Surgical Concepts (Asc) (1); Sur-Med Instruments, Inc. (1); The Kendal Co. (1).
Have FFO devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2024-12-03.
Next steps
- Run an FDA pathway report with predicate devices for product code FFO
- Run a recall and safety report across every FFO manufacturer
- Watch product code FFO 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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