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510(k) K211183

Sugita AVM Microclips by Mizuho America, Inc. — Product Code HCH

K211183 is an FDA 510(k) premarket notification submitted by Mizuho America, Inc. for the device "Sugita AVM Microclips". The FDA issued a decision of Substantially Equivalent on March 2, 2022. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. Mizuho America, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2022
Date Received
April 20, 2021
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 Mizuho America, Inc.

  • K221524 — Sugita AVM Microclip Applier (June 24, 2022)
  • K990202 — SUGITA TITANIUM ANEURYSM CLIP (June 4, 1999)
  • K960037 — SUGITA AVM MICROCLIP (February 5, 1997)
  • K955012 — MIZUHO RADIOLUCENT HEAD FRAME (September 12, 1996)

Other clearances for product code HCH

  • 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)
  • K024349 — AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER (March 24, 2003)

FDA data resources