510(k) K181488
K181488 is an FDA 510(k) premarket notification submitted by Ethicon Endo-Surgery, LLC for the device "LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier". The FDA issued a decision of Substantially Equivalent on October 30, 2018. 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 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 2018
- Date Received
- June 6, 2018
- Clearance Type
- Traditional
- 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