# K211183: Sugita AVM Microclips

- Pathway: 510(k) (Traditional)
- Applicant: Mizuho America, Inc.
- Decided: Mar 2, 2022 after 316 days
- Product code: HCH (Clip, Aneurysm)
- Device class: 2
- Regulation: 21 CFR 882.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K902544 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960037: Sugita Avm Microclip, Mizuho America, Inc. (1997) Summary page 4.

## Indications for use
The Sugita AVM Microclips are designed for occlusion of fragile capillary vessels to stop bleeding from arteriovenous malformations and other analogous venous structures. Sugita AVM Microclips are not intended as a replacement for bipolar electrocoagulation of smaller vessels nor do they negate the need for immediate post-operative angiography following arteriovenous malformation surgery.

Source page: https://510kreport.com/device/K211183
Methodology: https://510kreport.com/methodology