Cleared Traditional

K202554 - Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis (FDA 510(k) Clearance)

K202554 · Stryker Sustainability Solutions · General & Plastic Surgery device
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Mar 2021
Decision
194d
Days
-
Risk

K202554 is an FDA 510(k) clearance for the Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis. 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 March 16, 2021 after a review of 194 days - an extended review cycle.

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 K202554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2020
Decision Date March 16, 2021
Days to Decision 194 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
80d slower than avg
Panel avg: 114d · This submission: 194d
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 K202554.
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 1100 Shears, 5mm Diameter, 20cm length (HAR1120)
K233471 · Stryker Sustainability Solutions · Feb 2024