DIRECTVISION GUIDE SYSTEM— 510(k) K091600
Substantially EquivalentPercuvision, LLC
FDA 510(k) clearance K091600 for DIRECTVISION GUIDE SYSTEM, Substantially Equivalent on 2009-08-25. Applicant: Percuvision, LLC.
Clearance details
- Applicant
- Percuvision, LLC
- Product code
- Code FGC
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gahanna, OH, US
Adverse events under product code FGC
product code FGC- Malfunction
- 1,686
- Total
- 1,686
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.