DeviceClearance

Product code FAK— Gastroenterology, Urology

MODEL TX-8 PANENDOSCOPE

Classification name
Panendoscope (Gastroduodenoscope)
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

FDA classification 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).”

— U.S. Food and Drug Administration, device classification record for product code FAK under 21 CFR 876.1500, via openFDA

Market context for product code FAK

FDA has cleared 2 devices under product code FAK between 1976 and 1981, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code FAK

Recent clearances under product code FAK

Data sourced from openFDA. This site is unofficial and independent of the FDA.