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BioHealx Anal Fistula Device

SIGNUM SURGICAL LIMITED · Model BH201X1 · UDI-DI 05391546930001

QML Prescription
1
510(k) clearances
0
Adverse events
0
Recalls
4
Facilities

Description

The BioHealx Anal Fistula Device is indicated for closure of the internal opening of mature, cryptogenic, transsphincteric, non branching fistulas in ano via tissue apposition. BH201X1 is a single unit of the BioHealx Anal Fistula Device. Each single unti contains a single absorbable implant preloaded into a single use delivery system. It is provided sterile and is intended for single use. BH201X1 can be provided as a single unit or as a multipack of 5 units in a box.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.