Atlas FDA

NEUROPROBE

FDA 510(k) clearance K874018 · decided 1988-06-01

Clearance details

K-number
K874018
Device name
NEUROPROBE
Applicant
Inovx, Inc.
Decision
Substantially Equivalent
Date received
1987-10-02
Decision date
1988-06-01
Days to decision
243 days
Clearance type
Traditional
Product code
ETN
Device class
2
Regulation number
874.1820
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Los Altos, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Evala Nerve Stimulator (EPNR002) (K253536)Epineuron Technologies, Inc.2026-02-27
NIM 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) (K251672)Medtronic Xomed, Inc.2026-02-10
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) (K242852)Inomed Medizintechnik GmbH2025-06-13
Bioscope Neuromonitor Device (K233001)Biosys Biyomedikal Muhendislik San. VE Tic. A.S.2024-12-13
EARP Nerve Cuff Electrode (K241917)Retropsoas Technologies, LLC2024-07-31
Disposable Laryngeal Electrodes (K232888)Suzhou Haishen Medical Device Associates Co., Ltd.2023-12-21
NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube (K230320)Medtronic Xomed, Inc.2023-10-26
EARP Nerve Cuff Electrode (K230853)Nvision Biomedical Technologies, Inc.2023-10-06
NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) (K231580)Medtronic Xomed, Inc.2023-08-30
C2 Xplore (K223254)Inomed Medizintechnik GmbH2023-01-27
Mapping Suction Probe (K212164)Inomed Medizintechnik GmbH2022-11-11
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long (K213246)Medtronic Xomed, Inc.2022-03-21

Recalls involving this device

No recalls on record reference this clearance.