Atlas FDA

POREX NERVE LOCATOR

FDA 510(k) clearance K872791 · decided 1987-10-20

Clearance details

K-number
K872791
Device name
POREX NERVE LOCATOR
Applicant
Porex Medical
Decision
Substantially Equivalent
Date received
1987-07-14
Decision date
1987-10-20
Days to decision
98 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
Fairburn, GA, 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
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EARP Nerve Cuff Electrode (K241917)Retropsoas Technologies, LLC2024-07-31
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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
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Recalls involving this device

No recalls on record reference this clearance.