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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single-Use Reprocessed Ultrasonic Surgical Instruments
510(k) Number K250898
Device Name Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)
Applicant
Stryker Sustainability Solutions
1810 W Dr.Ake Dr.
Tempe,  AZ  85283
Applicant Contact Scott English
Correspondent
Stryker Sustainability Solutions
1810 W Dr.Ake Dr.
Tempe,  AZ  85283
Correspondent Contact Scott English
Classification Product Code
NLQ  
Date Received03/25/2025
Decision Date 08/14/2025
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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