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510(k) K240042

MOLLI 2 System by Molli Surgical, Inc. — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2024
Date Received
January 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Radiographic, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

Other clearances by Molli Surgical, Inc.

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  • K231579 — MOLLI 2 (October 26, 2023)
  • K223107 — MOLLI 2 (January 18, 2023)
  • K210600 — MOLLI (April 16, 2021)

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  • K251748 — MammoSTAR Biopsy Site Identifier (July 23, 2025)
  • K243642 — UltraCor™ Twirl™ Breast Tissue Marker (March 24, 2025)
  • K233639 — SmartClip Secure Soft Tissue Marker (December 20, 2024)
  • K240429 — Trilogy Tissue Marker (November 7, 2024)
  • K234149 — MOLLI 2 System (September 26, 2024)
  • K241762 — OneMark (September 16, 2024)