MODIFICATION TO ENDOTINE RIBBON— 510(k) K060828
Substantially EquivalentCoapt Systems, Inc.
FDA 510(k) clearance K060828 for MODIFICATION TO ENDOTINE RIBBON, Substantially Equivalent on 2006-04-19. Applicant: Coapt Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Coapt Systems, Inc.
- Product code
- Code GAM
- Device class
- Class 2
- Regulation
- 21 CFR 878.4493
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Palo Alto, CA, US
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More clearances from Coapt Systems, Inc.
view allAdverse events under product code GAM
product code GAM- Death
- 45
- Injury
- 5,711
- Malfunction
- 30,744
- Other
- 4
- Total
- 36,504
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.