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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K220890
Device Name IO Needle Safety Sheath
Applicant
Actuated Medical, Inc.
310 Rolling Ridge Dr.
Bellefonte,  PA  16823
Applicant Contact Douglas R. Dillon
Correspondent
Actuated Medical, Inc.
310 Rolling Ridge Dr.
Bellefonte,  PA  16823
Correspondent Contact Douglas R. Dillon
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/28/2022
Decision Date 10/31/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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