Cleared Traditional

K243642 - UltraCor™ Twirl™ Breast Tissue Marker (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243642 · Bard Peripheral Vascular, Inc. · General & Plastic Surgery device
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Mar 2025
Decision
118d
Days
Class 2
Risk

K243642 is an FDA 510(k) clearance for the UltraCor™ Twirl™ Breast Tissue Marker. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on March 24, 2025 after a review of 118 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - 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 Bard Peripheral Vascular, Inc. devices

Submission Details

510(k) Number K243642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2024
Decision Date March 24, 2025
Days to Decision 118 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 slower than avg
Panel avg: 114d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NEU Marker, Radiographic, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 - NEU Marker, Radiographic, Implantable

All 109
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K243642.
HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape)
K253761 · Devicor Medical Products, Inc. · Jan 2026
MOLLI 2 System
K253888 · Stryker Endoscopy · Dec 2025
SCOUT MD Surgical Guidance System
K252892 · Merit Medical Systems, Inc. · Dec 2025
VizMark Preloaded Tissue Marker Device (VM-0001)
K251989 · Breast-Med, Inc. · Dec 2025
MammoSTAR Biopsy Site Identifier
K251748 · Carbon Medical Technologies, Inc. · Jul 2025
SmartClip Secure Soft Tissue Marker
K233639 · Elucent Medical, Inc. · Dec 2024