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Chase Anastomosis Visualization Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K974568

by Chase Medical, Inc.

Identifiers

510(k) Number
K974568 FDA 510(k)
FDA Product Code
FQH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5475 FDA 510(k)
Regulation Number
880.5475 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Chase Anastomosis Visualization Device is a lavage, jet device designed to enhance surgical visibility during anastomosis procedures. It employs a malleable wand with a 0.2-micron filter and a sterile fluid inlet line to irrigate and clear wound sites, ensuring optimal visualization of the surgical field.

This device is supplied as a single-use, non-sterile item (sterilized prior to use) and is intended for use in general hospital settings. The malleable wand, approximately 10.125 inches in length, features a stainless steel wire embedded within its wall to maintain a user-defined shape. It has received FDA 510(k) clearance under the classification of Class II (FQH product code) and is regulated under 21 CFR 880.5475.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CHASE ANASTOMOSIS VISUALIZATION DEVICE - Innolitics, PDF Summary of Safety and Effectiveness Chase Anastomosis Visualization Device, K974568 FDA 510(k) - CHASE ANASTOMOSIS VISUALIZATION DEVICE, CHASE ANASTOMOSIS VISUALIZATION DEVICE 510 (k) K974568 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Chase Medical, Inc.

Sources (1)

  • FDA 510(k) K974568 24 fields · synced Sep 19, 2026