← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
HBL — Holder, Head, Neurosurgical (Skull Clamp)
DEVICE CLASS
Class II
REGULATION
21 CFR 882.4460
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES
Recent clearances
K250423Medical Bees GmbH · 510k2025-11-06
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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