ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP

• K Number: K091987
• Device Name: ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP
• Manufacturer: LEMAITRE VASCULAR, INC.
• Date Cleared: 2010-04-23 ( 295 days)
• Product Code: FZP , HBT
• Regulation Number: 878.4300
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

The AnastoClip GC is intended for use in the creation of everting anastomoses in blood vessels and other small tubular structures when tissue penetration is desired.

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the "Secure Grip Vessel Closure System (GripClip)". It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The 510(k) clearance process focuses on substantial equivalence to existing devices, and while it often references performance data, the details of such studies are typically not included in the clearance letter itself. These details would usually be found in the larger 510(k) submission.

Therefore, I cannot provide the requested table and study details based on the input text. The document only covers the regulatory clearance for the device.

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.