Decision Date2022-11-11
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Mapping Suction Probe is the device name listed in this FDA 510(k) record. The listed applicant is Inomed Medizintechnik GmbH. It received FDA 510(k) clearance on 2022-11-11 under 510(k) 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. The listed applicant is Inomed Medizintechnik GmbH. The 510(k) number is K212164.
When did Mapping Suction Probe receive FDA 510(k) clearance?
Mapping Suction Probe received FDA 510(k) clearance on 2022-11-11, under 510(k) number K212164.
Who is the listed applicant for Mapping Suction Probe?
The FDA 510(k) record lists Inomed Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Mapping Suction Probe?
The FDA product code for Mapping Suction Probe is ETN.
Other records listing Inomed Medizintechnik GmbH as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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)K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressK223254C2 XploreK212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressK152505C2 NerveMonitor System
Related Devices (Code: ETN)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K253536Evala Nerve Stimulator (EPNR002)Epineuron Technologies, Inc.K251672NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080)Medtronic Xomed, Inc.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)Inomed Medizintechnik GmbHK233001Bioscope Neuromonitor DeviceBiosys Biyomedikal Muhendislik San. VE Tic. A.S.K241917EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLCK232888Disposable 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.