FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020— 510(k) K022112

Clearance details

Applicant

Fortune Medical Instrument Corp.

Product code

Code KNT

Device class

Class 2

Regulation

21 CFR 876.5980

Advisory panel

Gastroenterology, Urology

Date received

2002-06-28

Decision date

2003-04-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Taipei Hsien, TW

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Death

192

Injury

6,034

Malfunction

4,049

Other

1

Total

10,276

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 →