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ViewPoint Suture, Nonabsorbable, Synthetic, Polypropylene

FDA 510(k)

Class II (US FDA 510(k))

510(k) K961168

by Philips Medical Systems (Cleveland), Inc.

Identifiers

510(k) Number
K961168 FDA 510(k)
FDA Product Code
GAW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.5010 FDA 510(k)
Regulation Number
878.5010 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ViewPoint is a suture, nonabsorbable, synthetic, polypropylene, designed for surgical applications. It is classified as a Class II medical device under FDA regulations and is intended for use in general and plastic surgery procedures, providing durable tissue approximation and wound closure.

This device is supplied as a reusable or single-use tool, depending on the specific surgical context, and is regulated under FDA 510(k) clearance (K961168). It is intended for use in sterile environments and is categorized under the product code GAW, adhering to FDA regulation 878.5010. The device is not MRI-safe unless explicitly stated otherwise in its packaging or instructions.

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: Philips Medical Systems (Cleveland), Inc. | D&B Business Directory, VIEWPOINT PASSIVE TOOL OPTION by PHILIPS MEDICAL SYSTEMS (CLEVELAND ..., Philips Medical Systems Inc: Cleveland, OH 44143 - Thomasnet

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Medical Systems (Cleveland), Inc.

Sources (1)

  • FDA 510(k) K961168 24 fields · synced Sep 19, 2026