BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF— 510(k) K912284
Substantially EquivalentDouglas James Donaldson Compliance Services
FDA 510(k) clearance K912284 for BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF, Substantially Equivalent on 1991-08-19. Applicant: Douglas James Donaldson Compliance Services. Device class: 2.
Clearance details
- Applicant
- Douglas James Donaldson Compliance Services
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oakland, CA, US
Recent devices under product code GEX
view allMore clearances from Douglas James Donaldson Compliance Services
view allAdverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
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.