MEDLINE GASTROSTOMY TUBE— 510(k) K073718
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K073718 for MEDLINE GASTROSTOMY TUBE, Substantially Equivalent on 2008-03-19. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code KGC
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Mundelein, IL, US
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Adverse events under product code KGC
product code KGC- Death
- 7
- Total
- 7
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.