FDA 510(k)
FDA class 2
Substantially Equivalent
🇵🇷 Puerto Rico
LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)
K Number: K232313
·
Decision Aug 29, 2023
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
175
Applicant Total
1
Review Days
27
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
- LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)
- K Number
- K232313
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ethicon Endo Surgery, LLC
- Date Received
- August 2, 2023
- Decision Date
- August 29, 2023
- Product Code
- FZP
- 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 |
|---|---|---|---|
| FZP | Clip, Implantable | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FZP), ordered by most recent decision date.
InnoClip Clip Applier
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
InnoClip Disposable Clip Applier
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Disposable Polymer Ligation Clips
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Hem-o-lok PurplePlus Large Polymer Ligating Clips
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GEM ZIPCLIP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOLID CLIP Single Use Clip Applier
FDA 510(k)
FDA Class 2
·General, Plastic Surgery