DeviceClearance

Product code FDA— Gastroenterology, Urology

Ancora-SB

Classification name
Enteroscope And Accessories
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
20
First cleared
Most recent

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).”

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

Market context for product code FDA

FDA has cleared 20 devices under product code FDA between 1981 and 2026, filed by 15 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 FDA

Adverse events under product code FDA

product code FDA
Death
8
Injury
148
Total
156

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 FDA

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