The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Ligaclip 10mm M/l Endoscopic Rotating Multiple Clip Applier.
| Device ID | K150840 |
| 510k Number | K150840 |
| Device Name: | Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier |
| Classification | Clip, Implantable |
| Applicant | ETHICON ENDO-SURGERY, LLC 475 CALLE C SUITE 202 Guaynabo, PR 00969 |
| Contact | Marjorie Medina |
| Correspondent | Emily Kruetzkamp ETHICON ENDO-SURGERY, INC. 4545 CREEK ROAD Cincinnati, OH 45242 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-30 |
| Decision Date | 2015-09-10 |
| Summary: | summary |