510(k) K183057— PUMA-G System
Substantially EquivalentCoaptech, LLC
Clearance details
- Applicant
- Coaptech, LLC
- Product code
- Code KGC
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baltimore, MD, 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.