DeviceClearance

K103426

Substantially Equivalent

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Applicant
Boston Scientific Corp
Product code
OTP
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Marlboro, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OTP

product code OTP
Injury
1,061
Total
1,061

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.