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The Sugita AVM Microclip Applier is exclusively designed to place Sugita AVM Microclips during surgical procedures.

The Sugita AVM Microclip Applier has a spring handle design with a ratchet. The Sugita AVM Microclip Applier serves to open and close the Sugita AVM Microclips. Using the Sugita AVM Microclip Applier, the Sugita AVM Microclips are removed from their packaging and applied, repositioned or removed from the target tissue. The Sugita AVM Microclip Applier has no function of its own and may only be used in combination with the Sugita AVM Microclips. The Sugita AVM Microclip Applier has the same design and materials as the clip applier in the K960037. The body of the Sugita AVM Microclip Applier is manufactured from stainless steel and the jaws are manufactured from Elgiloy, a cobalt-chromium-molybdenum alloy.

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.

The Sugita AVM Microclips were cleared by the FDA through 510(k) K960037. The Sugita AVM Microclips are manufactured from Elgiloy, a cobalt-chromiummolybdenum alloy. They are designed for the occlusion of fragile capillary vessels to stop bleeding from arteriovenous malformations and other analogous venous structures. The Sugita AVM Microclips are available in the following sizes: 2mm, 3mm, 4mm and 5mm. Other than the modifications identified above, there have been no other changes to the Sugita AVM Microclips.

The Sugita Titanium Aneurysm Clips of the permanent type are indicated for implantation for permanent occlusion of cerebral aneurysms. The temporary type are indicated for temporary occlusion of cerebral blood vessels.

The Sugita Titanium Aneurysm Clip is made from the titanium alloy Ti6AI4V. This alloy was chosen for the new clip because of its excellent compatibility with magnetic resonance imaging (MRI) devices. Titanium and its alloys cause much less artifact and are subject to much smaller magnetomechanical effects than other clips materials such as the cobalt-chrome alloys or stainless steel. Ti6Al4V also has excellent mechanical properties. The Sugita Titanium Aneurysm Clips are available in 55 models of various shapes and sizes. These shapes and sizes are identical to the corresponding models of the Sugita Elgiloy clips.

Occlusion of small vessels as a compliment to bipolar coagulation.

These devices are miniaturized versions of the currently marketed Sugita Aneurysm Clip. They are used to occlude small vessels when controlling bleeding on arteriovenous malformations or other similar venous structures.

Clamping of a patient's head and neck in a particular position during surgical procedures.

The device uses a four (4) point system to clamp a patient's head during surgical procedures. The material used was selected to reduce or eliminate interference normally associated with all metal skull clamps should x-rays or similar diagnostic activity be utilized during the procedure.