Cleared Traditional

K043315 - VANGUARD REPROCESSED HAND-ACTIVATED ULT...

K043315 · Vanguard Medical Concepts, Inc. · General & Plastic Surgery device
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Mar 2005
Decision
111d
Days
-
Risk

K043315 is an FDA 510(k) clearance for the VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL. Classified as Single-use Reprocessed Ultrasonic Surgical Instruments (product code NLQ).

Submitted by Vanguard Medical Concepts, Inc. (Lakeland, US). The FDA issued a Cleared decision on March 22, 2005 after a review of 111 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.

View all Vanguard Medical Concepts, Inc. devices

FDA 510(k) Submission Details - K043315

510(k) Number K043315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2004
Decision Date March 22, 2005
Days to Decision 111 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 faster than avg
Panel avg: 115d · This submission: 111d
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 K043315.
REPROCESSED ULTRASONIC SCALPELS
K043358 · Alliance Medical Corp. · Jun 2005
REPROCESSED HARMONIC SCALPELS
K050343 · Sterilmed, Inc. · Apr 2005
VANGUARD REPROCESSED ULTRASONIC SCALPEL
K043225 · Vanguard Medical Concepts, Inc. · Mar 2005
REPROCESSED HARMONIC
K012571 · Sterilmed, Inc. · Nov 2001