Cleared Traditional

SmartClip Secure Soft Tissue Marker (K233639) - FDA 510(k) Clearance

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

K233639 · Elucent Medical, Inc. · General & Plastic Surgery device
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Dec 2024
Decision
403d
Days
Class 2
Risk

K233639 is an FDA 510(k) clearance for the SmartClip Secure Soft Tissue Marker. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Elucent Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 20, 2024 after a review of 403 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Elucent Medical, Inc. devices

Submission Details

510(k) Number K233639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2023
Decision Date December 20, 2024
Days to Decision 403 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
288d slower than avg
Panel avg: 115d · This submission: 403d
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 47
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K233639.
VizMark Preloaded Tissue Marker Device (VM-0001)
K251989 · Breast-Med, Inc. · Dec 2025
MammoSTAR Biopsy Site Identifier
K251748 · Carbon Medical Technologies, Inc. · Jul 2025
UltraCor™ Twirl™ Breast Tissue Marker
K243642 · Bard Peripheral Vascular, Inc. · Mar 2025
Trilogy Tissue Marker
K240429 · Inrad, Inc. · Nov 2024
MOLLI 2 System
K234149 · Molli Surgical, Inc. · Sep 2024
MOLLI 2 System
K240042 · Molli Surgical, Inc. · Sep 2024