The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Weck Auto Endo10 Automatic Endoscopic Clip Applier.
| Device ID | K161758 |
| 510k Number | K161758 |
| Device Name: | Weck Auto Endo10 Automatic Endoscopic Clip Applier |
| Classification | Clip, Implantable |
| Applicant | TELEFLEX MEDICAL 3015 CARRINGTON MILL BLVD Morrisville, NC 27560 |
| Contact | Holly Hallock |
| Correspondent | Holly Hallock TELEFLEX MEDICAL 3015 CARRINGTON MILL BLVD Morrisville, NC 27560 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-27 |
| Decision Date | 2016-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44026704553134 | K161758 | 000 |
| 14026704553133 | K161758 | 000 |