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510(k) K954658

PERNECZKY CLIP APPLIER/REMOVER by Von Zeppelin GmbH — Product Code HCI

K954658 is an FDA 510(k) premarket notification submitted by Von Zeppelin GmbH for the device "PERNECZKY CLIP APPLIER/REMOVER". The FDA issued a decision of Substantially Equivalent on October 8, 1996. The device falls under product code HCI (Applier, Aneurysm Clip), a Class II device regulated under 21 CFR 882.4175. Von Zeppelin GmbH has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1996
Date Received
October 10, 1995
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

Other clearances by Von Zeppelin GmbH

  • K013091 — ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM (January 25, 2002)
  • K903151 — INTERVERTEBRAL DISC RONGEUR (December 11, 1990)
  • K901312 — PERNECZKY ANEURYSM CLIP (August 17, 1990)
  • K901313 — INSTRUMENTS FOR NEUROLOGICAL SURGERY (July 23, 1990)

Other clearances for product code HCI

  • K221524 — Sugita AVM Microclip Applier (June 24, 2022)
  • K211572 — Aesculap Slim Clip Applier (December 13, 2021)
  • K180914 — Aesculap Slim Clip Applier (April 17, 2018)
  • K173271 — Aesculap Slim Clip Applier Forceps (November 10, 2017)
  • K010910 — MEDICON YASARGIL CLIP APPLYING FORCEPS (August 1, 2001)
  • K994191 — SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T (February 8, 2000)
  • K984109 — AESCULAP AXIAL CLIP APPLIER (February 12, 1999)
  • K982379 — SUNDT SLIM-LINE ANEURYSM CLIP APPLIER (December 18, 1998)
  • K940970 — YASARGIL, CASPAR, VARIO CLIP APPLIERS (January 24, 1995)
  • K902544 — SUNDT AVM MICRO CLIP (September 20, 1990)

FDA data resources