510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984109Substantially Equivalent

Aesculap Axial Clip Applier

Aesculap Inc, South San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984109 is the FDA 510(k) clearance record for AESCULAP AXIAL CLIP APPLIER, a class II device, cleared for Aesculap, Inc. on under FDA product code HCI (Applier, Aneurysm Clip). FDA records list 269 510(k) clearances for Aesculap, Inc., from to . As of , FDA records show no recalls naming K984109.

Clearance record

Decision date
Received
(87 days to decision)
Product code
HCI Applier, Aneurysm Clip
Regulation
21 CFR 882.4175
Device class
Class II
Review panel
Neurology
Applicant
Aesculap, Inc. 1000 Gateway Blvd., South San Francisco CA
510(k) summary
Summary
Third party review
No

Clearances, product code HCI

Trailing 12 months

FDA records hold no clearances under product code HCI in the trailing twelve months.

FDA records show no clearances under product code HCI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HCI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260