OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167— 510(k) K073207
Substantially EquivalentCelon AG Medical Instruments
FDA 510(k) clearance K073207 for OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167, Substantially Equivalent on 2008-05-08. Applicant: Celon AG Medical Instruments. Device class: 2.
Clearance details
- Applicant
- Celon AG Medical Instruments
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Center Valley, PA, US
Recent devices under product code GEI
view allMore clearances from Celon AG Medical Instruments
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.