The following data is part of a premarket notification filed by Covidien with the FDA for Premium Surgiclip¿; Endo Clip¿; Acuclip¿.
| Device ID | K143644 |
| 510k Number | K143644 |
| Device Name: | Premium Surgiclip¿; Endo Clip¿; AcuClip¿ |
| Classification | Clip, Implantable |
| Applicant | COVIDIEN 60 Middletown Ave North Haven, CT 06473 |
| Contact | Michael Koczocik |
| Correspondent | Michael Koczocik COVIDIEN 60 Middletown Ave North Haven, CT 06473 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-22 |
| Decision Date | 2015-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521057524 | K143644 | 000 |
| 20884521057545 | K143644 | 000 |
| 20884521057552 | K143644 | 000 |
| 20884521057569 | K143644 | 000 |
| 20884521057576 | K143644 | 000 |
| 20884521057804 | K143644 | 000 |
| 20884521057835 | K143644 | 000 |
| 20884521057842 | K143644 | 000 |
| 20884521057866 | K143644 | 000 |
| 20884521057873 | K143644 | 000 |
| 20884521057538 | K143644 | 000 |