510(k) clearances

StimTrial Neuromodulation System

Bioventus, LLC · Neurology

K253877Substantially EquivalentSpecialGZF
Open FDA's page for this record
Third party flag
N
City
Durham
Advisory committee description
Neurology
Address 1
4721 Emperor Blvd., Suite 100
Statement or summary
Summary
Product code
GZF
Zip code
27703
Applicant
Bioventus, LLC
Decision date
2026-08-26
Decision code
SESE
Country code
US
Device name
StimTrial Neuromodulation System
Advisory committee
NE
Contact
Sageev George
K number
K253877
State
NC
Date received
2025-12-04
Review advisory committee
NE
Postal code
27703
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Medical specialty description
Neurology
Regulation number
882.5870
Device class
2
Registration number
3015425075, 3009183442, 3019807891, 3016547665, 3016618265, 3004209178, 3002672225, 1422634, 1627487, 2030624, 3022631685, 3010676138, 2135338, 2183744, 2649622, 3027669735, 3008988055, 3009595577, 3024996452, 1928237, 2246552, 3013023969, 3008255748, 3012266672, 3009166798, 2182207, 2032521, 3018094310
FEI number
3015425075, 3009183442, 3019807891, 3016547665, 3016618265, 3002672225, 1627487, 3005700659, 1000514656, 3022631685, 3010676138, 3004369318, 2183744, 2649622, 3027669735, 3008988055, 3009595577, 3024996452, 1928237, 2246552, 3000206435, 3013023969, 3008255748, 3012266672, 3009166798, 2182207, 3003574398, 3018094310
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.