510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K013136Substantially Equivalent

Aneurysm Clips

Gistlstrasse, Pullach, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013136 is the FDA 510(k) clearance record for ANEURYSM CLIPS, a class II device, cleared for Gistlstrasse on under FDA product code HCH (Clip, Aneurysm). FDA records list one 510(k) clearance for Gistlstrasse. As of , FDA records show no recalls naming K013136.

Clearance record

Decision date
Received
(68 days to decision)
Product code
HCH Clip, Aneurysm
Regulation
21 CFR 882.5200
Device class
Class II
Review panel
Neurology
Applicant
Gistlstrasse Gistlstrasse 99, Pullach, DE
510(k) summary
Summary
Third party review
No

Clearances, product code HCH

Trailing 12 months

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

FDA records show no clearances under product code HCH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HCH, 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