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510(k) K223107

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2023
Date Received
September 30, 2022
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.

  • K234149 — MOLLI 2 System (September 26, 2024)
  • K240042 — MOLLI 2 System (September 25, 2024)
  • K231579 — MOLLI 2 (October 26, 2023)
  • K210600 — MOLLI (April 16, 2021)

Other clearances for product code NEU

  • K253761 — HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Bre (January 23, 2026)
  • K253888 — MOLLI 2 System (December 31, 2025)
  • K252892 — SCOUT MD Surgical Guidance System (December 19, 2025)
  • K251989 — VizMark Preloaded Tissue Marker Device (VM-0001) (December 12, 2025)
  • 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)
  • K240042 — MOLLI 2 System (September 25, 2024)