DeviceClearance

Product code FBK— Gastroenterology, Urology

INJECTION NEEDLE

Classification name
Endoscopic Injection Needle, Gastroenterology-Urology
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
89
First cleared
Most recent

FDA classification definition

“inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.”

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

Market context for product code FBK

FDA has cleared 89 devices under product code FBK between 1981 and 2026, filed by 66 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 FBK

Adverse events under product code FBK

product code FBK
Other
1
Total
1

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 FBK

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