iSnare system-Lariat— 510(k) K152035
Substantially EquivalentUnited States Endoscopy Group, Inc.
FDA 510(k) clearance K152035 for iSnare system-Lariat, Substantially Equivalent on 2015-10-15. Applicant: United States Endoscopy Group, Inc..
Clearance details
- Applicant
- United States Endoscopy Group, Inc.
- Product code
- Code FBK
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mentor, OH, US
Adverse events under product code FBK
product code FBK- Other
- 1
- Total
- 1
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.