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Suture Washer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K954148

by Acu Med, Inc.

Identifiers

510(k) Number
K954148 FDA 510(k)
FDA Product Code
HTN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3030 FDA 510(k)
Regulation Number
888.3030 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Suture Washer is a Washer, Bolt (product code HTN) designed for orthopedic applications. It is intended to secure sutures or fixation devices in soft tissue, small bone, and large bone procedures, ensuring stable attachment during surgical repair.

This device is supplied as a reusable medical instrument and is cleared for use in orthopedic settings. It is classified as a Class 2 device under FDA regulations and was granted FDA 510(k) clearance (K954148) through the Traditional pathway in 1996. No specific sterility or MRI safety information is provided in the available data.

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: K954148 - SUTURE WASHER | FDA 510 (k) | Acu Med, Inc., SUTURE WASHER (K954148) — FDA 510(k) | Innolitics, ACUMED SUTURE WASHER (K965028) — FDA 510 (k) | Innolitics, PDF K965028 - Acumed Suture Washer, ACUMED SUTURE WASHER 510 (k) K965028 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Acu Med, Inc.

Sources (1)

  • FDA 510(k) K954148 24 fields · synced Sep 19, 2026