FDA product code FAM: Sigmoidoscope And Accessories, Flexible/Rigid
FAM is the FDA product code for sigmoidoscope and accessories, flexible/rigid. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 24 510(k) submissions under FAM, from 11 different applicants. The average 510(k) review took 92 days (median 66). FDA has posted 2 recalls for FAM devices.
Definition
to examine and perform procedures within the sigmoid (descending) colon
Classification
| Field | Value |
|---|---|
| Device name | Sigmoidoscope And Accessories, Flexible/Rigid |
| 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 FAM clearance
Top FAM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pentax Precision Instrument Corp. | 6 | 1996-06-24 |
| Vision-Sciences, Inc. | 5 | 1997-01-03 |
| Welch Allyn, Inc. | 4 | 1997-04-17 |
| American Optical Corp. | 2 | 1982-04-01 |
| Akos Biomedical, Inc. | 1 | 1997-06-27 |
6 more applicants have FAM clearances. See the full list in Caduvo.
Most recent FAM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K964131 | Akos Biomedical, Inc. | ENDOSCOPE | 1997-06-27 | 255 |
| K970382 | Welch Allyn, Inc. | VS-100 VIDEO SIGMOIDOSCOPE | 1997-04-17 | 73 |
| K964326 | Vision-Sciences, Inc. | VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM | 1997-01-03 | 65 |
| K964100 | Vision-Sciences, Inc. | VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100 | 1996-12-16 | 66 |
| K963344 | Vision-Sciences, Inc. | DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE | 1996-11-21 | 87 |
Recalls for FAM devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-04-06.
Frequently asked questions
What is FDA product code FAM?
FAM is the FDA product code for sigmoidoscope and accessories, flexible/rigid. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FAM?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FAM?
Across 24 cleared submissions the average was 92 days from receipt to decision (median 66).
Which companies have the most FAM clearances?
Pentax Precision Instrument Corp. (6); Vision-Sciences, Inc. (5); Welch Allyn, Inc. (4); American Optical Corp. (2); Akos Biomedical, Inc. (1).
Have FAM devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2016-04-06.
Next steps
- Run an FDA pathway report with predicate devices for product code FAM
- Run a recall and safety report across every FAM manufacturer
- Watch product code FAM 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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