FDA 510(k)

Nerve Tape

N.º K: K210665 · 2022-07-15

SolicitanteBiocircuit Technologies, Incorporated

Fecha de decisión2022-07-15

Código de productoJXI

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Nerve Tape is the device name listed in this FDA 510(k) record. The listed applicant is Biocircuit Technologies, Incorporated. It received FDA 510(k) clearance on 2022-07-15 under 510(k) number K210665. The device is classified under product code JXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Nerve Tape?

Nerve Tape is a medical device that received FDA 510(k) clearance on 2022-07-15. The listed applicant is Biocircuit Technologies, Incorporated. The 510(k) number is K210665.

When did Nerve Tape receive FDA 510(k) clearance?

Nerve Tape received FDA 510(k) clearance on 2022-07-15, under 510(k) number K210665.

Who is the listed applicant for Nerve Tape?

The FDA 510(k) record lists Biocircuit Technologies, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nerve Tape?

The FDA product code for Nerve Tape is JXI.

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Dispositivos relacionados (Código: JXI)

K260245SILKBridgeKLISBio S.r.l.K253363NeuroSpan BridgeAuxilium Biotechnologies, Inc.K251505VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)Alafair Biosciences K251175VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)Alafair Biosciences K243889Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)Orthocell, Ltd.K242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc.

Fuente oficial

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