Skip to content

Parker Quality & Compliance

PQC Reg Watch

Sponsor this week — one slot, $75, newsletter line and this bar

Device type

Nasopharyngoscope (Flexible Or Rigid)

Product code EOB · Class II · 21 CFR 874.4760 · Ear, Nose, Throat

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