Atlas FDA

KXG

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Applicator, Absorbent Tipped, Sterile
Device class
Class I (low risk)
Regulation
21 CFR 880.6025
Medical specialty
General Hospital
Adverse events (MAUDE)
2015: 10 · 2016: 10 · 2020: 160 · 2021: 406 · 2022: 65 · 2023: 33
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PROFILE SWAB CAT.#5273 & 5274 (K802004)Pollak (Intl.), Ltd.1980-09-16

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