IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT— 510(k) K102572
Substantially EquivalentSainath Intellectual Properties, LLC
FDA 510(k) clearance K102572 for IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT, Substantially Equivalent on 2010-12-27. Applicant: Sainath Intellectual Properties, LLC.
Clearance details
- Applicant
- Sainath Intellectual Properties, LLC
- Product code
- Code KNT
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tampa, FL, US
Adverse events under product code KNT
product code KNT- Death
- 192
- Injury
- 6,034
- Malfunction
- 4,049
- Other
- 1
- Total
- 10,276
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.