510(k) K905282— ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE
UnknownFrantz Medical Development, Ltd.
Clearance details
- Applicant
- Frantz Medical Development, Ltd.
- Product code
- Code GCT
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- New York, NY, US
Adverse events under product code GCT
product code GCT- Malfunction
- 1,393
- Other
- 2
- Total
- 1,395
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.