Smith & Nephew Suture Collet

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

510(k) Number

K971939 ↗

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 Smith & Nephew Endoscopy, Inc. →

• What types of endoscopic procedures is the Smith & Nephew Suture Collet designed to assist with, and how does it compare to traditional suturing methods?

  The Smith & Nephew Suture Collet is specifically designed for soft tissue fixation and vessel ligation during endoscopic procedures in gastroenterology and urology. Unlike traditional USP size 2-0 knotted silk suture, it provides a mechanical alternative for approximating soft tissue structures without requiring manual suturing. This makes it useful for procedures where precise tissue alignment is needed, but traditional suturing may be challenging or time-consuming.

• Is the Suture Collet intended for reuse, or is it meant to be used only once per patient?

  The device is supplied sterile and explicitly intended for single-use only in endoscopic settings. This ensures patient safety by preventing cross-contamination and maintaining sterility between procedures.

• How is the Suture Collet regulated in the U.S., and what does its classification mean for clinical use?

  The Smith & Nephew Suture Collet is classified as a Class II medical device under FDA regulation 876.1500, meaning it undergoes premarket notification (510(k)) review to demonstrate substantial equivalence to a legally marketed predicate device. Its 510(k) clearance (K971939) confirms it meets FDA standards for safety and effectiveness as a mechanical alternative to USP size 2-0 silk suture in endoscopic procedures.

• Are there different sizes or models of the Suture Collet, and how would I determine which one to use?

  While the provided data does not specify exact sizes or model variations, the device is designed to approximate soft tissue and ligate vessels during endoscopic procedures. Selection would typically depend on the specific anatomical requirements of the procedure (e.g., tissue thickness or vessel diameter). Consulting the manufacturer’s instructions or a product catalog would provide precise sizing guidance, as the device is tailored to replace USP size 2-0 suture applications.