DeviceClearance

Product code ODF— Gastroenterology, Urology

5 STAR MEDICAL ENDOSCOPE

Classification name
Mini Endoscope, Gastroenterology-Urology
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
12
First cleared
Most recent

FDA classification definition

“To examine and perform procedures in body cavities of the GI and GU tract. 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 ODF under 21 CFR 876.1500, via openFDA

Market context for product code ODF

FDA has cleared 12 devices under product code ODF between 1988 and 2010, filed by 8 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 ODF

Recent clearances under product code ODF

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