510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081489Substantially Equivalent

L-Aneurysm-Clip System & L-Aneurysm Clip Appliers, Yasargil Aneurysm Clips & Yasargil Aneurysm Clip Appliers

Peter Lazic GmbH, Mühlheim An Der Donau, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081489 is the FDA 510(k) clearance record for L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS, a class II device, cleared for Peter Lazic GmbH on under FDA product code HCH (Clip, Aneurysm). FDA records list 2 510(k) clearances for Peter Lazic GmbH, from to . As of , FDA records show 2 recalls naming K081489.

Clearance record

Decision date
Received
(120 days to decision)
Product code
HCH Clip, Aneurysm
Regulation
21 CFR 882.5200
Device class
Class II
Review panel
Neurology
Applicant
Peter Lazic GmbH Griesweg 47, Mühlheim An Der Donau, DE
510(k) summary
Summary PDF
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