FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
MOLLI 2 System
K Number: K240042
·
Decision Sep 25, 2024
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
109
Applicant Total
5
Review Days
264
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MOLLI 2 System
- K Number
- K240042
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Molli Surgical, Inc.
- Date Received
- January 5, 2024
- Decision Date
- September 25, 2024
- Product Code
- NEU
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NEU | Marker, Radiographic, Implantable | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NEU), ordered by most recent decision date.
HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MOLLI 2 System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCOUT MD Surgical Guidance System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VizMark Preloaded Tissue Marker Device (VM-0001)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MammoSTAR Biopsy Site Identifier
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UltraCor Twirl Breast Tissue Marker
FDA 510(k)
FDA Class 2
·General, Plastic Surgery