510(k) K232313
K232313 is an FDA 510(k) premarket notification submitted by Ethicon Endo Surgery, LLC for the device "LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)". The FDA issued a decision of Substantially Equivalent on August 29, 2023. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Ethicon Endo Surgery, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 2023
- Date Received
- August 2, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type