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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope Accessory
510(k) Number K252874
Device Name Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
Applicant
Serpex Medical, Inc.
3350 Scott Blvd.
Suite 37b
Santa Clara,  CA  95054
Applicant Contact Neil Zimmerman
Correspondent
Serpex Medical, Inc.
3350 Scott Blvd.
Suite 37b
Santa Clara,  CA  95054
Correspondent Contact Diane Horwitz
Regulation Number874.4680
Classification Product Code
KTI  
Date Received09/10/2025
Decision Date 10/08/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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