510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954658Substantially Equivalent

Perneczky Clip Applier/remover

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

K954658 is the FDA 510(k) clearance record for PERNECZKY CLIP APPLIER/REMOVER, a class II device, cleared for Von Zeppelin GmbH on under FDA product code HCI (Applier, Aneurysm Clip). FDA records list 5 510(k) clearances for Von Zeppelin GmbH, from to . As of , FDA records show no recalls naming K954658.

Clearance record

Decision date
Received
(364 days to decision)
Product code
HCI Applier, Aneurysm Clip
Regulation
21 CFR 882.4175
Device class
Class II
Review panel
Neurology
Applicant
Von Zeppelin GmbH Gistlstrasse 99, Pullach, DE
510(k) summary
Statement
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