Device type
Endoscopic Injection Needle, Gastroenterology-Urology
Product code FBK · Class II · 21 CFR 876.1500 · Gastroenterology, Urology
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
Recent 510(k)s
No 510(k) clearances in the archive for FBK.
Recent recalls
Oct 21, 2026
Z-0163-2027
Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Orde…
Cook Incorporated
- FBK
- Class II
- Ongoing