FAKClass II
Panendoscope (Gastroduodenoscope)
21 CFR 876.1500 / Gastroenterology, Urology
FAK is the FDA product code for Panendoscope (Gastroduodenoscope), a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "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)". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- FAK
- Device name
- Panendoscope (Gastroduodenoscope)
- FDA 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).
- Regulation
- 21 CFR 876.1500
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code FAK
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1981 | 1 |
Applicants with the most clearances
Product code FAK| Applicant | Clearances |
|---|---|
| American Cystocope Makers, Inc. | 1 |
| Pentax Precision Instrument Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code FAK.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.