510(k) K984109
K984109 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "AESCULAP AXIAL CLIP APPLIER". The FDA issued a decision of Substantially Equivalent on February 12, 1999. The device falls under product code HCI (Applier, Aneurysm Clip), a Class II device regulated under 21 CFR 882.4175. Aesculap, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 1999
- Date Received
- November 17, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applier, Aneurysm Clip
- Device Class
- Class II
- Regulation Number
- 882.4175
- Review Panel
- NE
- Submission Type