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510(k) K010910

MEDICON YASARGIL CLIP APPLYING FORCEPS by Medicon EG — Product Code HCI

K010910 is an FDA 510(k) premarket notification submitted by Medicon EG for the device "MEDICON YASARGIL CLIP APPLYING FORCEPS". The FDA issued a decision of Substantially Equivalent on August 1, 2001. The device falls under product code HCI (Applier, Aneurysm Clip), a Class II device regulated under 21 CFR 882.4175. 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
Applier, Aneurysm Clip
Device Class
Class II
Regulation Number
882.4175
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)
  • K010908 — MEDICON TITANIUM YASARGIL ANEURYSM CLIPS (August 1, 2001)
  • K972857 — SERVOTRONIC EC100 SYSTEM (January 16, 1998)

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)
  • 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)
  • K954658 — PERNECZKY CLIP APPLIER/REMOVER (October 8, 1996)
  • K940970 — YASARGIL, CASPAR, VARIO CLIP APPLIERS (January 24, 1995)
  • K902544 — SUNDT AVM MICRO CLIP (September 20, 1990)

FDA data resources