Cleared Traditional

K190610 - Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology (FDA 510(k) Clearance)

K190610 · Sterilmed, Inc. · General & Plastic Surgery device
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Aug 2019
Decision
157d
Days
-
Risk

K190610 is an FDA 510(k) clearance for the Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology. Classified as Single-use Reprocessed Ultrasonic Surgical Instruments (product code NLQ).

Submitted by Sterilmed, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 15, 2019 after a review of 157 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.

View all Sterilmed, Inc. devices

Submission Details

510(k) Number K190610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2019
Decision Date August 15, 2019
Days to Decision 157 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 114d · This submission: 157d
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 K190610.
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
Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis
K202554 · Stryker Sustainability Solutions · Mar 2021