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FDA 510(k)

Mapping Suction Probe

K-Number: K212164 · 2022-11-11

ApplicantInomed Medizintechnik GmbH
Decision Date2022-11-11
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Mapping Suction Probe is a medical device manufactured by Inomed Medizintechnik GmbH. It received FDA 510(k) clearance on 2022-11-11 under approval number K212164. 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 Mapping Suction Probe?

Mapping Suction Probe is a medical device that received FDA 510(k) clearance on 2022-11-11. It is manufactured by Inomed Medizintechnik GmbH. The 510(k) number is K212164.

When was Mapping Suction Probe approved by the FDA?

Mapping Suction Probe received FDA 510(k) clearance on 2022-11-11, under approval number K212164.

What company makes Mapping Suction Probe?

Mapping Suction Probe is manufactured by Inomed Medizintechnik GmbH.

What is the FDA product code for Mapping Suction Probe?

The FDA product code for Mapping Suction Probe is ETN.

Other Devices by Inomed Medizintechnik GmbH

K152505C2 NerveMonitor System K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress K223254C2 Xplore 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 K213246NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm LongMedtronic Xomed, Inc. K232888Disposable Laryngeal ElectrodesSuzhou Haishen Medical Device Associates Co., Ltd.

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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