FDA

Enteroscope And Accessories

Product code

FDA

Device name

Enteroscope And Accessories

Device class

Class 2

21 CFR

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

3

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

20 (all years; only the last 3 years are listed here)

FDA classification definition

To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-05-01.

2 summaries are archived here for direct download.