Y-Knot Suture Clip

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Innovasive Devices Y-Knot Suture Clip

510(k) Number

K973313 ↗

FDA Product Code

OCW

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Innovasive Devices, Inc. →

• What is the Y-Knot Suture Clip used for?

  The Y-Knot Suture Clip is designed for securing and ligating soft tissue during endoscopic surgical procedures. It approximates tissue edges or ligates vessels, reducing the need for sutures in specific applications within gastroenterology and urology. This is particularly useful where precise tissue control is required, such as in minimally invasive surgeries.

• Is the Y-Knot Suture Clip single-use or reusable?

  The Y-Knot Suture Clip is supplied as a single-use device. It is non-sterile and must be sterilized prior to use in a controlled clinical setting. This ensures patient safety and maintains device integrity for one-time application.

• How should the Y-Knot Suture Clip be sterilized?

  The Y-Knot Suture Clip is non-sterile and requires sterilization before use. The manufacturer recommends following standard sterilization protocols appropriate for endoscopic devices, such as autoclaving or ethylene oxide sterilization, to ensure it is safe for sterile application in surgical environments.

• What are the regulatory approvals for the Y-Knot Suture Clip?

  The Y-Knot Suture Clip holds an FDA 510(k) clearance with the determination of Substantially Equivalent (SESE) under the classification 876.1500. This clearance indicates that the device meets regulatory standards for endoscopic tissue approximation devices and is authorized for use in the United States.

• What endoscopic specialties is the Y-Knot Suture Clip intended for?

  The Y-Knot Suture Clip is specifically intended for use in gastroenterology and urology procedures. It is designed to assist in securing tissue during endoscopic surgeries where precise control and approximation are critical, such as in the gastrointestinal or urinary tracts.