Tutopatch, Tutomesh

FDA 510(k) K081538 · Rti Biologics, Inc.

Substantially Equivalent

510(k) numberK081538

Submission

Device name
Tutopatch, Tutomesh
Applicant
Rti Biologics, Inc.
Alachua, FL, US
Received
June 2, 2008
Decision date
June 19, 2008
Decision
Substantially Equivalent (SESE)
Type
Special 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 Tutopatch, Tutomesh cleared by the FDA?

Tutopatch, Tutomesh (K081538) received a 510(k) decision of Substantially Equivalent on June 19, 2008, 17 days after the submission was received.

What is the product code of K081538?

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