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Parker Quality & Compliance

PQC Reg Watch

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Device type

Endoscope, Neurological

Product code GWG · Class II · 21 CFR 882.1480 · Neurology

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

FDA classification database

Recent 510(k)s

Recent recalls

No recalls in the archive for GWG.