K801503
Substantially EquivalentHOLLISTER KARAYA SEAL RING
- Applicant
- Hollister, Inc.
- Product code
- EXB
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code EXB
product code EXB- Injury
- 145
- Total
- 145
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.