Cleared Traditional

K030598 - MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS (FDA 510(k) Clearance)

K030598 · Medisiss · General & Plastic Surgery device
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Jan 2004
Decision
332d
Days
-
Risk

K030598 is an FDA 510(k) clearance for the MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS. Classified as Single-use Reprocessed Ultrasonic Surgical Instruments (product code NLQ).

Submitted by Medisiss (Sisters, US). The FDA issued a Cleared decision on January 23, 2004 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medisiss devices

Submission Details

510(k) Number K030598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2003
Decision Date January 23, 2004
Days to Decision 332 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
218d slower than avg
Panel avg: 114d · This submission: 332d
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 K030598.
Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm)
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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