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510(k) K901312

PERNECZKY ANEURYSM CLIP by Von Zeppelin GmbH — Product Code HCH

K901312 is an FDA 510(k) premarket notification submitted by Von Zeppelin GmbH for the device "PERNECZKY ANEURYSM CLIP". The FDA issued a decision of Substantially Equivalent on August 17, 1990. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. Von Zeppelin GmbH has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1990
Date Received
March 20, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Aneurysm
Device Class
Class II
Regulation Number
882.5200
Review Panel
NE
Submission Type

Other clearances by Von Zeppelin GmbH

  • K013091 — ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM (January 25, 2002)
  • K954658 — PERNECZKY CLIP APPLIER/REMOVER (October 8, 1996)
  • K903151 — INTERVERTEBRAL DISC RONGEUR (December 11, 1990)
  • K901313 — INSTRUMENTS FOR NEUROLOGICAL SURGERY (July 23, 1990)

Other clearances for product code HCH

  • K211183 — Sugita AVM Microclips (March 2, 2022)
  • K180757 — D-Clip; D-Clip Applier (April 12, 2019)
  • K131500 — YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS (January 24, 2014)
  • K091921 — CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REI (September 8, 2009)
  • K081640 — GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS (May 6, 2009)
  • K081489 — L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YAS (September 25, 2008)
  • K060915 — KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APP (April 17, 2007)
  • K043041 — AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) (December 9, 2004)
  • K032198 — AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP (August 20, 2003)
  • K031468 — TEMPORARY TITANIUM ANEURYSM CLIP (June 20, 2003)

FDA data resources