SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228— 510(k) K990864
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K990864 for SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228, Substantially Equivalent on 1999-06-11. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code MND
- Device class
- Class 2
- Regulation
- 21 CFR 876.4400
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Natick,, MA, US
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Adverse events under product code MND
product code MND- Death
- 6
- Injury
- 255
- Malfunction
- 4,495
- Total
- 4,756
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.