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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PROFILE SWAB CAT.#5273 & 5274 (K802004) | Pollak (Intl.), Ltd. | 1980-09-16 |
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