SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311— 510(k) K101270
Substantially EquivalentExcelsior Medical Corp.
FDA 510(k) clearance K101270 for SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311, Substantially Equivalent on 2011-02-10. Applicant: Excelsior Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Excelsior Medical Corp.
- Product code
- Code NGT
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dundas, On, CA
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More clearances from Excelsior Medical Corp.
view allAdverse events under product code NGT
product code NGT- Death
- 12
- Malfunction
- 2,008
- Other
- 4
- Total
- 2,024
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.