The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Ligaclip 12mm L Endoscopic Rotating Multiple Clip Applier.
| Device ID | K181488 |
| 510k Number | K181488 |
| Device Name: | LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier |
| Classification | Clip, Implantable |
| Applicant | Ethicon Endo-Surgery, LLC 475 Calle C Suite 202 Guynabo, PR 00969 |
| Contact | Sigfrido Delgado |
| Correspondent | Melissa Iwu Ethicon Endo-Surgery, Inc 4545 Creek Rd Cincinnati, OH 45245 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-06 |
| Decision Date | 2018-10-30 |
| Summary: | summary |