Biodesign Enterocutaneous Fistula Plug

FDA 510(k) K150668 · Cook Biotech Incorprated

Substantially Equivalent

510(k) numberK150668

Submission

Device name
Biodesign Enterocutaneous Fistula Plug
Applicant
Cook Biotech Incorprated
West Lafayette, IN, US
Received
March 16, 2015
Decision date
December 9, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FTM – Mesh, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Specialty
General, Plastic Surgery
Implant
Yes

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Questions and answers

When was Biodesign Enterocutaneous Fistula Plug cleared by the FDA?

Biodesign Enterocutaneous Fistula Plug (K150668) received a 510(k) decision of Substantially Equivalent on December 9, 2015, 268 days after the submission was received.

What is the product code of K150668?

The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.