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External Vein Stripper

FDA 510(k)

Class II (US FDA 510(k))

510(k) K933498

by Applied Medical Resources

Identifiers

510(k) Number
K933498 FDA 510(k)
FDA Product Code
DWX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.4875 FDA 510(k)
Regulation Number
870.4875 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The External Vein Stripper is a cardiovascular device designed for the surgical treatment of incompetent and dilated superficial veins. It is specifically intended for the stripping of the great and small saphenous veins.

This device is supplied for use in surgical settings and has received FDA 510(k) clearance. It is classified as a class 2 medical device under regulation number 870.4875.

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: EXTERNAL VEIN STRIPPER (K933498) — FDA 510(k) | Innolitics, Venostrip® - B. Braun, Vein strippers - Varicose vein treatment | Vygon

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Applied Medical Resources

Sources (1)

  • FDA 510(k) K933498 24 fields · synced Sep 21, 2026