Bio Fluff System
FDA 510(k) clearance K201861 · decided 2022-03-02
Clearance details
- K-number
- K201861
- Device name
- Bio Fluff System
- Applicant
- Gnali Bocia S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2020-07-06
- Decision date
- 2022-03-02
- Days to decision
- 604 days
- Clearance type
- Traditional
- Product code
- KPL
- Device class
- 2
- Regulation number
- 876.5220
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lumezzane, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.