ValPro 2 Plus, VaPro 2 Plus Pocket— 510(k) K183253
Substantially EquivalentHollister Incorporated
FDA 510(k) clearance K183253 for ValPro 2 Plus, VaPro 2 Plus Pocket, Substantially Equivalent on 2018-12-18. Applicant: Hollister Incorporated.
Clearance details
- Applicant
- Hollister Incorporated
- Product code
- Code GBM
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Libertyville, IL, US
Adverse events under product code GBM
product code GBM- Injury
- 397
- Malfunction
- 1,404
- Total
- 1,801
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.