Cleared Traditional

K043358 - REPROCESSED ULTRASONIC SCALPELS

K043358 · Alliance Medical Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jun 2005
Decision
182d
Days
-
Risk

K043358 is an FDA 510(k) clearance for the REPROCESSED ULTRASONIC SCALPELS. Classified as Single-use Reprocessed Ultrasonic Surgical Instruments (product code NLQ).

Submitted by Alliance Medical Corp. (Phoenix, US). The FDA issued a Cleared decision on June 6, 2005 after a review of 182 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 Alliance Medical Corp. devices

FDA 510(k) Submission Details - K043358

510(k) Number K043358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2004
Decision Date June 06, 2005
Days to Decision 182 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
67d slower than avg
Panel avg: 115d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

NLQ Device Classification - Class 0,

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 19
Devices cleared under the same product code (NLQ) and FDA review panel - the closest regulatory comparables to K043358.
REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY
K133672 · Stryker Sustainability Solutions · May 2014
REPROCESSED HARMONIC SCALPEL
K111794 · Sterilmed, Inc. · Jan 2012
REPROCESSED HARMONIC SCALPEL
K083060 · Sterilmed, Inc. · Jan 2009
REPROCESSED HARMONIC SCALPELS
K050343 · Sterilmed, Inc. · Apr 2005
VANGUARD REPROCESSED ULTRASONIC SCALPEL
K043225 · Vanguard Medical Concepts, Inc. · Mar 2005
VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL
K043315 · Vanguard Medical Concepts, Inc. · Mar 2005