FlexBand Plus

FDA 510(k) K192112 · International Life Sciences

Substantially Equivalent

510(k) numberK192112

Submission

Device name
FlexBand Plus
Applicant
International Life Sciences
Marietta, GA, US
Received
August 5, 2019
Decision date
September 27, 2019
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FTL – Mesh, Surgical, Polymeric
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 FlexBand Plus cleared by the FDA?

FlexBand Plus (K192112) received a 510(k) decision of Substantially Equivalent on September 27, 2019, 53 days after the submission was received.

What is the product code of K192112?

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