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510(k) K221524

Sugita AVM Microclip Applier by Mizuho America, Inc. — Product Code HCI

K221524 is an FDA 510(k) premarket notification submitted by Mizuho America, Inc. for the device "Sugita AVM Microclip Applier". The FDA issued a decision of Substantially Equivalent on June 24, 2022. The device falls under product code HCI (Applier, Aneurysm Clip), a Class II device regulated under 21 CFR 882.4175. Mizuho America, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2022
Date Received
May 26, 2022
Clearance Type
Special
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 Mizuho America, Inc.

  • K211183 — Sugita AVM Microclips (March 2, 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 HCI

  • 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)
  • K010910 — MEDICON YASARGIL CLIP APPLYING FORCEPS (August 1, 2001)
  • 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