Lariat, Hot/Cold Snare— 510(k) K200745
Substantially EquivalentUnited States Endoscopy Group, Inc.
FDA 510(k) clearance K200745 for Lariat, Hot/Cold Snare, Substantially Equivalent on 2020-04-21. Applicant: United States Endoscopy Group, Inc..
Clearance details
- Applicant
- United States Endoscopy Group, Inc.
- Product code
- Code FDI
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mentor, OH, US
Adverse events under product code FDI
product code FDI- Death
- 6
- Injury
- 217
- Malfunction
- 1,544
- Total
- 1,767
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.