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510(k) K833650

YASARGIL STANDARD ANEURYSM CLIP & by Advanced Biosearch Assn. — Product Code HCH

K833650 is an FDA 510(k) premarket notification submitted by Advanced Biosearch Assn. for the device "YASARGIL STANDARD ANEURYSM CLIP &". The FDA issued a decision of Substantially Equivalent on January 18, 1984. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. Advanced Biosearch Assn. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1984
Date Received
October 19, 1983
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 Advanced Biosearch Assn.

  • K905514 — AUTOGENESIS(TM) AUTOMATOR (April 2, 1991)
  • K883888 — CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. (December 12, 1988)
  • K854770 — MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM (February 11, 1986)
  • K855030 — CHAMPY BONE PLATES & BONE SCREWS (January 30, 1986)
  • K855031 — MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE P (January 21, 1986)
  • K853916 — P.M. HIP-FEMORAL PROSTHESIS (December 27, 1985)
  • K852839 — FREEMAN HIP (October 29, 1985)
  • K853418 — SAFTI-BRACELET (September 20, 1985)
  • K852517 — CLS HIP PROSTHESIS (September 18, 1985)
  • K852699 — FREEMAN ACETABULAR CUP (September 5, 1985)

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