Cleared Traditional

K233471 - Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120) (FDA 510(k) Clearance)

Also includes:
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)
K233471 · Stryker Sustainability Solutions · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
118d
Days
-
Risk

K233471 is an FDA 510(k) clearance for the Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120). Classified as Single-use Reprocessed Ultrasonic Surgical Instruments (product code NLQ).

Submitted by Stryker Sustainability Solutions (Tempe, US). The FDA issued a Cleared decision on February 20, 2024 after a review of 118 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K233471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2023
Decision Date February 20, 2024
Days to Decision 118 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 114d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

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).

Regulatory Peers - NLQ Single-use Reprocessed Ultrasonic Surgical Instruments

All 26
Devices cleared under the same product code (NLQ) and FDA review panel - the closest regulatory comparables to K233471.
Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm)
K250898 · Stryker Sustainability Solutions · Aug 2025
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120)
K241606 · Stryker Sustainability Solutions · Jul 2024
Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis
K202554 · Stryker Sustainability Solutions · Mar 2021