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FDA 510(k)

C2 Xplore

K-Number: K223254 · 2023-01-27

ApplicantInomed Medizintechnik GmbH
Decision Date2023-01-27
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

C2 Xplore is a medical device manufactured by Inomed Medizintechnik GmbH. It received FDA 510(k) clearance on 2023-01-27 under approval number K223254. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C2 Xplore?

C2 Xplore is a medical device that received FDA 510(k) clearance on 2023-01-27. It is manufactured by Inomed Medizintechnik GmbH. The 510(k) number is K223254.

When was C2 Xplore approved by the FDA?

C2 Xplore received FDA 510(k) clearance on 2023-01-27, under approval number K223254.

What company makes C2 Xplore?

C2 Xplore is manufactured by Inomed Medizintechnik GmbH.

What is the FDA product code for C2 Xplore?

The FDA product code for C2 Xplore is ETN.

Other Devices by Inomed Medizintechnik GmbH

K152505C2 NerveMonitor System K212164Mapping Suction Probe K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress K242852ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)

Related Devices (Code: ETN)

K152769FREMAP ELECTRODEAd-Tech Medical Instrument Corporation K152505C2 NerveMonitor SystemInomed Medizintechnik GmbH K200886StimSiteAllotrope Medical, Inc. K212355Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, LargeCheckpoint Surgical K212164Mapping Suction ProbeInomed Medizintechnik GmbH K213246NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm LongMedtronic Xomed, Inc.

Official Source

View on FDA Database →

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

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