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510(k) K242852

ALM 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) by Inomed Medizintechnik GmbH — Product Code ETN

K242852 is an FDA 510(k) premarket notification submitted by Inomed Medizintechnik GmbH for the device "ALM 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)". The FDA issued a decision of Substantially Equivalent on June 13, 2025. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Inomed Medizintechnik GmbH has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2025
Date Received
September 20, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve
Device Class
Class II
Regulation Number
874.1820
Review Panel
EN
Submission Type

Other clearances by Inomed Medizintechnik GmbH

  • K233292 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (October 27, 2023)
  • K223254 — C2 Xplore (January 27, 2023)
  • K212164 — Mapping Suction Probe (November 11, 2022)
  • K212166 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (January 7, 2022)
  • K152505 — C2 NerveMonitor System (February 1, 2016)
  • K111647 — C2 NERVEMONITOR SYSTEM WITH ACCESSORIES (October 6, 2011)
  • K091874 — INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 (November 18, 2009)
  • K042208 — ISIS MER SYSTEM/ELEKTA MER SYSTEM (March 18, 2005)
  • K910972 — WALTER GRAPHTEK (October 2, 1991)

Other clearances for product code ETN

  • K253536 — Evala Nerve Stimulator (EPNR002) (February 27, 2026)
  • K251672 — NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tu (February 10, 2026)
  • K233001 — Bioscope Neuromonitor Device (December 13, 2024)
  • K241917 — EARP Nerve Cuff Electrode (July 31, 2024)
  • K232888 — Disposable Laryngeal Electrodes (December 21, 2023)
  • K230320 — NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotrache (October 26, 2023)
  • K230853 — EARP Nerve Cuff Electrode (October 6, 2023)
  • K231580 — NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) (August 30, 2023)
  • K223254 — C2 Xplore (January 27, 2023)
  • K212164 — Mapping Suction Probe (November 11, 2022)

FDA data resources