K132658 is an FDA 510(k) clearance for the HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).
Submitted by Teleflex Medical (Durham, US). The FDA issued a Cleared decision on November 27, 2013, 93 days after receiving the submission on August 26, 2013.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K132658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2013 |
| Decision Date | November 27, 2013 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FZP — Clip, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |