ULTRACONCENTRATOR SYSTEM— 510(k) K011148

Clearance details

Applicant

Interpore Cross Intl.

Product code

Code FJI

Device class

Class 2

Regulation

21 CFR 876.5820

Advisory panel

Gastroenterology, Urology

Date received

2001-04-16

Decision date

2001-06-13

Decision

Substantially Equivalent

Clearance type

Special

Location

Irvine, CA, US

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Death

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →