MOLLI 2 System

FDA 510(k) K240042 · Molli Surgical, Inc.

Substantially Equivalent

510(k) numberK240042

Submission

Device name
MOLLI 2 System
Applicant
Molli Surgical, Inc.
Toronto, CA
Received
January 5, 2024
Decision date
September 25, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NEU – Marker, Radiographic, Implantable
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4300
Specialty
General, Plastic Surgery
Implant
Yes

Other 510(k)s with product code NEU

510(k)DeviceApplicantDecision
K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast…NEU · Traditional Devicor Medical Products, Inc.01/23/2026SE
K253888MOLLI 2 SystemNEU · Special Stryker Endoscopy12/31/2025SE
K252892SCOUT MD Surgical Guidance SystemNEU · Traditional Merit Medical Systems, Inc.12/19/2025SE
K251989VizMark Preloaded Tissue Marker Device (VM-0001)NEU · Traditional Breast-Med, Inc.12/12/2025SE
K251748MammoSTAR Biopsy Site IdentifierNEU · Traditional Carbon Medical Technologies, Inc.07/23/2025SE
K243642UltraCor™ Twirl™ Breast Tissue MarkerNEU · Traditional Bard Peripheral Vascular, Inc.03/24/2025SE
K233639SmartClip Secure Soft Tissue MarkerNEU · Traditional Elucent Medical, Inc.12/20/2024SE
K240429Trilogy Tissue MarkerNEU · Traditional Inrad, Inc.11/07/2024SE
K234149MOLLI 2 SystemNEU · Traditional Molli Surgical, Inc.09/26/2024SE
K241762OneMarkNEU · Traditional View Point Medical09/16/2024SE

More from View Point Medical

510(k)DeviceDecision
K234149MOLLI 2 SystemNEU · Traditional 09/26/2024SE
K231579Molli 2NEU · Traditional 10/26/2023SE
K223107Molli 2NEU · Traditional 01/18/2023SE
K210600MolliNEU · Traditional 04/16/2021SE

Questions and answers

When was MOLLI 2 System cleared by the FDA?

MOLLI 2 System (K240042) received a 510(k) decision of Substantially Equivalent on September 25, 2024, 264 days after the submission was received.

What is the product code of K240042?

The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.