510(k) clearances

CIONIC NEURAL SLEEVE (NS-200)

Cionic, Inc. · Neurology

K243828Substantially EquivalentTraditionalGZI
Open FDA's page for this record
Third party flag
N
City
Scotts Valley
Advisory committee description
Neurology
Address 1
1500 Green Hills Rd. Suite 109
Statement or summary
Summary
Product code
GZI
Zip code
95066
Applicant
Cionic, Inc.
Decision date
2025-05-02
Decision code
SESE
Country code
US
Device name
CIONIC NEURAL SLEEVE (NS-200)
Advisory committee
NE
Contact
Mihai Ionescu
K number
K243828
State
CA
Date received
2024-12-13
Review advisory committee
PM
Postal code
95066
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Stimulator, Neuromuscular, External Functional
Medical specialty description
Neurology
Regulation number
882.5810
Device class
2
Registration number
3007502541, 3005170249, 9611612, 3019892999, 3013927823, 3019822804, 3005344585, 8040537, 3036471706, 2011115, 3005713796, 3049809930, 3027669735, 3010362721, 3020683829, 3038295706, 3005694504, 3007543044, 3004438577, 3009437400, 3017264244, 3046040683, 3038197172, 3004076349, 3012651177, 3006141275, 2013558, 3044563261, 3013503259, 3005868392, 9616086, 3008008477, 3004733458, 3012316249, 3030418885, 3008525454, 3009538657, 1721293, 9617486
FEI number
3007502541, 3005170249, 3019892999, 3013927823, 3019822804, 3005344585, 3036471706, 2011115, 3005713796, 3049809930, 3027669735, 3010362721, 3020683829, 3038295706, 3005694504, 3007543044, 3004438577, 3009437400, 3002807847, 3017264244, 3046040683, 3038197172, 3004076349, 3012651177, 3006141275, 3005154439, 2013558, 3006076154, 3044563261, 3013503259, 3005868392, 3008008477, 3004733458, 3012316249, 3030418885, 3008525454, 3009538657, 1721293, 1000442645
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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.