Cleared Special

Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)

K241606 · Stryker Sustainability Solutions · General & Plastic Surgery
Jul 2024
Decision
29d
Days
—
Risk

About This 510(k) Submission

K241606 is an FDA 510(k) clearance for the Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136), a Single-use Reprocessed Ultrasonic Surgical Instruments, submitted by Stryker Sustainability Solutions (Tempe, US). The FDA issued a Cleared decision on July 3, 2024, 29 days after receiving the submission on June 4, 2024. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K241606 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2024
Decision Date July 03, 2024
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code NLQ — Single-use Reprocessed Ultrasonic Surgical Instruments
Device Class —
Definition Single-use Reprocessed Versions Of The Ultrasonic Devices Used In Surgical Procedures Either For Fragmentation, Emulsification And Aspiration Of Soft Tissue And Hard Tissue Or For Ligation Of Vessels (under Product Code ?lfl?). Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission.. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).

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