Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit— 510(k) K153506
Substantially EquivalentConsure Medical Pvt , Ltd.
FDA 510(k) clearance K153506 for Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit, Substantially Equivalent on 2016-05-06. Applicant: Consure Medical Pvt , Ltd.. Device class: 2.
Clearance details
- Applicant
- Consure Medical Pvt , Ltd.
- Product code
- Code KNT
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Delhi, IN
Recent devices under product code KNT
view allMore clearances from Consure Medical Pvt , Ltd.
view allAdverse 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.