NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735— 510(k) K021196

Substantially Equivalent

Neuron Therapeutics, Inc.

FDA 510(k) clearance K021196 for NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735, Substantially Equivalent on 2002-07-01. Applicant: Neuron Therapeutics, Inc..

Clearance details

Applicant: Neuron Therapeutics, Inc.
Product code: Code JXG
Advisory panel: Neurology
Date received: 2002-04-16
Decision date: 2002-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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Adverse events under product code JXG

product code JXG

Death: 76
Injury: 5,632
Malfunction: 2,230
Other: 4
Total: 7,942

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.