VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726— 510(k) K002650
Substantially EquivalentBentec Medical, Inc.
FDA 510(k) clearance K002650 for VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726, Substantially Equivalent on 2001-02-16. Applicant: Bentec Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Bentec Medical, Inc.
- Product code
- Code FGE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Woodland, CA, US
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More clearances from Bentec Medical, Inc.
view allAdverse events under product code FGE
product code FGE- Death
- 52
- Injury
- 2,347
- Malfunction
- 9,798
- Other
- 1
- Total
- 12,198
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.