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510(k) Data Aggregation
K Number
K201861Device Name
Bio Fluff System
Manufacturer
Gnali Bocia S.R.L.
Date Cleared
2022-03-02
(604 days)
Product Code
KPL
Regulation Number
876.5220Why did this record match?
Applicant Name (Manufacturer) :
Gnali Bocia S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bio Fluff System is intended for colon cleansing to remove fecal residues when medically indicated, such as before radiological or endoscopic examination.
Device Description
The Bio Fluff System is intended to instill water through a disposable speculum into the colon. Intestinal Cleansing is carried out by inserting water in the patient's rectum at controlled temperature and pressure through the disposable specula. This action allows the cleaning of the lower tract of the colon. The Bio Fluff System comprises:
- different models of the Bio Fluff device:
- HT model, for professional use,
- HTP model, portable version of HT model,
- associated components:
- disposable HT specula for both Bio Fluff model HT and Bio Fluff model HTP.
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