AMT Suture Delivery System— 510(k) K193612
Substantially EquivalentApplied Medical Technology, Inc.
FDA 510(k) clearance K193612 for AMT Suture Delivery System, Substantially Equivalent on 2020-03-12. Applicant: Applied Medical Technology, Inc..
Clearance details
- Applicant
- Applied Medical Technology, Inc.
- Product code
- Code KGC
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brecksville, OH, US
Adverse events under product code KGC
product code KGC- Death
- 7
- Total
- 7
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.