PROSYS LEG BAG— 510(k) K952208
Substantially EquivalentConvatec, A Division of E.R. Squibb & Sons
FDA 510(k) clearance K952208 for PROSYS LEG BAG, Substantially Equivalent on 1995-08-15. Applicant: Convatec, A Division of E.R. Squibb & Sons.
Clearance details
- Applicant
- Convatec, A Division of E.R. Squibb & Sons
- Product code
- Code KNX
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Skillman, NJ, US
Adverse events under product code KNX
product code KNX- Malfunction
- 1,064
- Total
- 1,064
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.