FDA product code FAK: Panendoscope (Gastroduodenoscope)
FAK is the FDA product code for panendoscope (gastroduodenoscope). It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under FAK, from 2 different applicants. The average 510(k) review took 25 days (median 25).
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification
| Field | Value |
|---|---|
| Device name | Panendoscope (Gastroduodenoscope) |
| 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 FAK clearance
Top FAK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pentax Precision Instrument Corp. | 1 | 1981-11-17 |
| American Cystocope Makers, Inc. | 1 | 1976-10-21 |
Most recent FAK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K812810 | Pentax Precision Instrument Corp. | PENTAX FLEXIBLE DRIODENOFIBERSCOPE | 1981-11-17 | 42 |
| K760822 | American Cystocope Makers, Inc. | MODEL TX-8 PANENDOSCOPE | 1976-10-21 | 8 |
Recalls for FAK devices
openFDA lists no recalls for product code FAK.
Frequently asked questions
What is FDA product code FAK?
FAK is the FDA product code for panendoscope (gastroduodenoscope). It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FAK?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FAK?
Across 2 cleared submissions the average was 25 days from receipt to decision (median 25).
Which companies have the most FAK clearances?
Pentax Precision Instrument Corp. (1); American Cystocope Makers, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FAK
- Run a recall and safety report across every FAK manufacturer
- Watch product code FAK 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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