Cleared Traditional

MOLLI 2 (K223107) - FDA 510(k) Clearance

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

K223107 · Molli Surgical, Inc. · General & Plastic Surgery device
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Jan 2023
Decision
110d
Days
Class 2
Risk

K223107 is an FDA 510(k) clearance for the MOLLI 2. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Molli Surgical, Inc. (Toronto, CA). The FDA issued a Cleared decision on January 18, 2023 after a review of 110 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 Molli Surgical, Inc. devices

Submission Details

510(k) Number K223107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2022
Decision Date January 18, 2023
Days to Decision 110 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 115d · This submission: 110d
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 K223107.
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MOLLI
K210600 · Molli Surgical, Inc. · Apr 2021