← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
FBK — Endoscopic Injection Needle, Gastroenterology-Urology
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
DEVICE CLASS
Class II
REGULATION
21 CFR 876.1500
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES
Recent clearances
K260262Mirco-Tech (Nanjing) Co., Ltd. · 510k2026-05-29
K253598Carbon Medical Technologies, Inc. · 510k2026-03-31
K252021Changzhou New Med Micro-Medtech Co., Ltd. · 510k2025-12-02
K252247Olympus Medical Systems Corporation · 510k2025-10-16
K241595Veol Medical Technologies Pvt , Ltd. · 510k2025-02-27
K240675Promisemed Hangzhou Meditech Co., Ltd. · 510k2024-10-04
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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