K250898

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)

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 AZ · US
Product code
NLQ — Single-Use Reprocessed Ultrasonic Surgical Instrumen
Decision date
2025-08-14
Date received
2025-03-25
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Unknown
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain

Also available from FDA: K250898.pdf

Official FDA record: K250898
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.