K984109 is an FDA 510(k) clearance for the AESCULAP AXIAL CLIP APPLIER. This device is classified as a Applier, Aneurysm Clip (Class II - Special Controls, product code HCI).
Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on February 12, 1999, 87 days after receiving the submission on November 17, 1998.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4175.
| 510(k) Number | K984109 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 1998 |
| Decision Date | February 12, 1999 |
| Days to Decision | 87 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 |