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510(k) K010908

MEDICON TITANIUM YASARGIL ANEURYSM CLIPS by Medicon EG — Product Code HCH

K010908 is an FDA 510(k) premarket notification submitted by Medicon EG for the device "MEDICON TITANIUM YASARGIL ANEURYSM CLIPS". The FDA issued a decision of Substantially Equivalent on August 1, 2001. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. Medicon EG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2001
Date Received
March 26, 2001
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 Medicon EG

  • K161680 — MEDICON Spinal Spreading Systems (March 24, 2017)
  • K100916 — MEDICON MOGEN CLAMP (December 6, 2010)
  • K083803 — FIXIT HEADREST CLAMP SYSTEM (March 10, 2010)
  • K053624 — MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM (July 17, 2006)
  • K050478 — MEDICON IMF-ORION SCREWS (June 15, 2005)
  • K043297 — MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM (February 23, 2005)
  • K042974 — MEDICON VIPAIR HIGH SPEED SYSTEM (January 13, 2005)
  • K041527 — AARHUS ANCHORAGE SYSTEM (August 19, 2004)
  • K010910 — MEDICON YASARGIL CLIP APPLYING FORCEPS (August 1, 2001)
  • K972857 — SERVOTRONIC EC100 SYSTEM (January 16, 1998)

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