Cleared Traditional

K043594 - VANGUARD REPROCESSED BLADED TROCAR

K043594 is an FDA 510(k) clearance for VANGUARD REPROCESSED BLADED TROCAR, manufactured by Vanguard Medical Concepts, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code NLM cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K043594 · Vanguard Medical Concepts, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2005
Decision
92d
Days
Class 2
Risk

K043594 is an FDA 510(k) clearance for the VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES. Classified as Laparoscope, General & Plastic Surgery, Reprocessed (product code NLM), Class II - Special Controls.

Submitted by Vanguard Medical Concepts, Inc. (Lakeland, US). The FDA issued a Cleared decision on March 31, 2005 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vanguard Medical Concepts, Inc. devices

FDA 510(k) Submission Details - K043594

510(k) Number K043594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2004
Decision Date March 31, 2005
Days to Decision 92 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 130d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NLM Device Classification - Class 2, Special Controls

Product Code NLM Laparoscope, General & Plastic Surgery, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition The "endoscope And Accessories, Reprocessed" Is Intended To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals. This Device Is Indicated For Reuse/reprocessing. 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - NLM Laparoscope, General & Plastic Surgery, Reprocessed

All 11
Devices cleared under the same product code (NLM) and FDA review panel - the closest regulatory comparables to K043594.
REPROCESSED ENDOSCOPIC TROCAR
K052299 · Sterilmed, Inc. · May 2006
REPROCESSED ENDOSCOPIC TROCAR
K043592 · Sterilmed, Inc. · May 2005
VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS
K043253 · Vanguard Medical Concepts, Inc. · Apr 2005
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
K024015 · Alliance Medical Corp. · Mar 2003
REPROCESSED ENDOSCOPIC TROCAR
K012578 · Sterilmed, Inc. · Nov 2001