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FDA 510(k)

SUGITA AVM MICROCLIP

K-Number: K960037 · 1997-02-05

ApplicantMizuho America, Inc.
Decision Date1997-02-05
Product CodeHCH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SUGITA AVM MICROCLIP is the device name listed in this FDA 510(k) record. The listed applicant is Mizuho America, Inc.. It received FDA 510(k) clearance on 1997-02-05 under 510(k) number K960037. The device is classified under product code HCH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUGITA AVM MICROCLIP?

SUGITA AVM MICROCLIP is a medical device that received FDA 510(k) clearance on 1997-02-05. The listed applicant is Mizuho America, Inc.. The 510(k) number is K960037.

When did SUGITA AVM MICROCLIP receive FDA 510(k) clearance?

SUGITA AVM MICROCLIP received FDA 510(k) clearance on 1997-02-05, under 510(k) number K960037.

Who is the listed applicant for SUGITA AVM MICROCLIP?

The FDA 510(k) record lists Mizuho America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUGITA AVM MICROCLIP?

The FDA product code for SUGITA AVM MICROCLIP is HCH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mizuho America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221524Sugita AVM Microclip ApplierK211183Sugita AVM MicroclipsK990202SUGITA TITANIUM ANEURYSM CLIPK955012MIZUHO RADIOLUCENT HEAD FRAME

Related Devices (Code: HCH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211183Sugita AVM MicroclipsMizuho America, Inc.K180757D-Clip; D-Clip ApplierPeter Lazic GmbHK091921CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIPCodman & Shurtleff, Inc.K081640GIMMI ANEURYSM CLIPS AND APPLYING FORCEPSGimmi GmbHK081489L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERSPeter Lazic GmbHK060915KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERSKirwan Surgical Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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