DeviceClearance

Product code FDS— Gastroenterology, Urology

EvoEndo Single-Use Endoscopy System

Classification name
Gastroscope And Accessories, Flexible/Rigid
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
78
First cleared
Most recent

FDA classification definition

“To examine or perform procedures in the stomach. 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).”

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

Market context for product code FDS

FDA has cleared 78 devices under product code FDS between 1983 and 2026, filed by 36 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

last 15 years

Top applicants under product code FDS

Adverse events under product code FDS

product code FDS
Death
37
Injury
863
Malfunction
56,442
Other
1
Total
57,343

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code FDS

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