Bioteque A.V. Fistula Needle Set

by Bioteque Corp. FDA registration: Taiwan 510(k)

510(k) K993118 Product code FIE

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK993118	Date17 Dec 1999Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number: K993118
FDA Product Code: FIE

Device Class: Class II
Regulation: 21 CFR Part 876.5540
Advisory Committee: Gastroenterology, Urology
FDA Decision: SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K993118 24 fields · synced 22 Oct 2026