The following data is part of a premarket notification filed by Ethicon Endo Surgery, Inc. with the FDA for Ligaclip 5 M/l Mm Endoscopic Multiple Clip Applier.
| Device ID | K050344 |
| 510k Number | K050344 |
| Device Name: | LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER |
| Classification | Clip, Implantable |
| Applicant | ETHICON ENDO SURGERY, INC. 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Kimberly Shoemaker |
| Correspondent | Kimberly Shoemaker 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 | 2005-02-11 |
| Decision Date | 2005-03-14 |
| Summary: | summary |