FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020— 510(k) K022112
Substantially EquivalentFortune Medical Instrument Corp.
FDA 510(k) clearance K022112 for FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020, Substantially Equivalent on 2003-04-03. Applicant: Fortune Medical Instrument Corp..
Clearance details
- Applicant
- Fortune Medical Instrument Corp.
- Product code
- Code KNT
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taipei Hsien, TW
Adverse events under product code KNT
product code KNT- Death
- 192
- Injury
- 6,034
- Malfunction
- 4,049
- Other
- 1
- Total
- 10,276
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.