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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Coring (Huber) Needle
510(k) Number K254095
Device Name 25G Huber Needle
Applicant
Martech Medical Products
1500 Delp Dr.
Harleysville,  PA  19438
Applicant Contact Ashley Rolfe
Correspondent
Martech Medical Products
1500 Delp Dr.
Harleysville,  PA  19438
Correspondent Contact Ashley Rolfe
Regulation Number880.5570
Classification Product Code
PTI  
Subsequent Product Code
FPA  
Date Received12/19/2025
Decision Date 09/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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