DEVICE CLASS
Class II
REGULATION
21 CFR 882.1320
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
18
510(K)/PMA CLEARANCES
510k: 18
0
RECALL ENTRIES
Recent clearances
K260578Ambu A/S · 510k2026-07-14
K261442Cadwell Industries, Inc. · 510k2026-06-26
K261522Biowave Corporation · 510k2026-06-03
K253237Elde Medikal Sanayi ve Ticaret Anonim Sirketi · 510k2026-05-08
K254183Technomed Europe · 510k2026-05-07
K252439Dongguan Tutamen Metalwork Co., Ltd. · 510k2026-05-01
K253256Otto Bock Healthcare Products GmbH · 510k2026-04-22
K260363Ceribell, Inc. · 510k2026-04-03
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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