Surgisis Nerve Cuff

FDA 510(k) K031069 · Cook Biotech, Inc.

Substantially Equivalent

510(k) numberK031069

Submission

Device name
Surgisis Nerve Cuff
Applicant
Cook Biotech, Inc.
West Lafayette, IN, US
Received
April 4, 2003
Decision date
May 15, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JXI – Cuff, Nerve
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5275
Specialty
Neurology
Implant
Yes

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Questions and answers

When was Surgisis Nerve Cuff cleared by the FDA?

Surgisis Nerve Cuff (K031069) received a 510(k) decision of Substantially Equivalent on May 15, 2003, 41 days after the submission was received.

What is the product code of K031069?

The FDA product code is JXI – Cuff, Nerve, a Class II (moderate risk) device regulated under 21 CFR 882.5275.