FAK — Panendoscope (Gastroduodenoscope) Class II

FDA Device Classification

Classification Details

Product Code: FAK
Device Class: Class II
Regulation Number: 876.1500
Submission Type
Review Panel: GU
Medical Specialty: Gastroenterology, Urology
Implant: No

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).

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K812810	pentax precision instrument	PENTAX FLEXIBLE DRIODENOFIBERSCOPE	November 17, 1981
K760822	american cystocope makers	MODEL TX-8 PANENDOSCOPE	October 21, 1976