510(k) K233628

AOS Interstitial Templates, Needles, and Accessories by Alpha-Omega Services, Inc. — Product Code JAQ

K233628 is an FDA 510(k) premarket notification submitted by Alpha-Omega Services, Inc. for the device "AOS Interstitial Templates, Needles, and Accessories". The FDA issued a decision of Substantially Equivalent on July 10, 2024. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Alpha-Omega Services, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2024
Date Received
November 13, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type