Atlas FDA

RF INTRODUCTION CANNULA

FDA 510(k) clearance K041021 · decided 2004-09-16

Clearance details

K-number
K041021
Device name
RF INTRODUCTION CANNULA
Applicant
Epimed International, Inc.
Decision
Substantially Equivalent
Date received
2004-04-20
Decision date
2004-09-16
Days to decision
149 days
Clearance type
Traditional
Product code
GXI
Device class
2
Regulation number
882.4725
Medical specialty
Neurology
Advisory committee
Neurology
Location
Johnstown, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257 recall (Z-1849-2020)Epimed International2020-04-16
R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257 recall (Z-1850-2020)Epimed International2020-04-16