Scion Saphenous Vein Harvesting System

FDA 510(k) K963006 · Scion International, Inc.

Substantially Equivalent

510(k) numberK963006

Submission

Device name
Scion Saphenous Vein Harvesting System
Applicant
Scion International, Inc.
Miami, FL, US
Received
August 2, 1996
Decision date
September 20, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GAD – Retractor
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

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Questions and answers

When was Scion Saphenous Vein Harvesting System cleared by the FDA?

Scion Saphenous Vein Harvesting System (K963006) received a 510(k) decision of Substantially Equivalent on September 20, 1996, 49 days after the submission was received.

What is the product code of K963006?

The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.