FDA 510(k)

VALUTRODE NEUROSTIMLATION ELECTRODES

K-Number: K130987 · 2013-07-17

Decision Date2013-07-17

Product CodeGXY

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

VALUTRODE NEUROSTIMLATION ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Axelgaard Mfg. Co., Ltd.. It received FDA 510(k) clearance on 2013-07-17 under 510(k) number K130987. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VALUTRODE NEUROSTIMLATION ELECTRODES?

VALUTRODE NEUROSTIMLATION ELECTRODES is a medical device that received FDA 510(k) clearance on 2013-07-17. The listed applicant is Axelgaard Mfg. Co., Ltd.. The 510(k) number is K130987.

When did VALUTRODE NEUROSTIMLATION ELECTRODES receive FDA 510(k) clearance?

VALUTRODE NEUROSTIMLATION ELECTRODES received FDA 510(k) clearance on 2013-07-17, under 510(k) number K130987.

Who is the listed applicant for VALUTRODE NEUROSTIMLATION ELECTRODES?

The FDA 510(k) record lists Axelgaard Mfg. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VALUTRODE NEUROSTIMLATION ELECTRODES?

The FDA product code for VALUTRODE NEUROSTIMLATION ELECTRODES is GXY.

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Other records listing Axelgaard Mfg. Co., Ltd. as applicant

K080580COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D K013532ULTRASTIM KIT K000947ULTRASTIM ELECTRODE, MODEL US4040 K000206PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 K983741EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 K970426VALUETRODE

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.