Cleared Traditional

K241145 - TLAB® Transvenous Liver Biopsy System (TF-18C)

K241145 is an FDA 510(k) clearance for TLAB Transvenous Liver Biopsy System (T..., manufactured by Argon Medical Devices, Inc.. The device is a Class 2 General & Plastic Surgery device with product code DYB cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K241145 · Argon Medical Devices, Inc. · General & Plastic Surgery device
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Aug 2024
Decision
98d
Days
Class 2
Risk

K241145 is an FDA 510(k) clearance for the TLAB® Transvenous Liver Biopsy System (TF-18C). Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on August 1, 2024 after a review of 98 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 870.1340 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Argon Medical Devices, Inc. devices

FDA 510(k) Submission Details - K241145

510(k) Number K241145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2024
Decision Date August 01, 2024
Days to Decision 98 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
17d faster than avg
Panel avg: 115d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 595
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