K180914 is an FDA 510(k) clearance for the Aesculap Slim Clip Applier. This device is classified as a Applier, Aneurysm Clip (Class II - Special Controls, product code HCI).
Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on April 17, 2018, 8 days after receiving the submission on April 9, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4175.
| 510(k) Number | K180914 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2018 |
| Decision Date | April 17, 2018 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCI — Applier, Aneurysm Clip |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4175 |