RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90— 510(k) K992693
Substantially EquivalentRita Medical Systems
FDA 510(k) clearance K992693 for RITA MODEL 90 ELECTROSURGICAL ACCESSORY, MODEL 90, Substantially Equivalent on 1999-09-10. Applicant: Rita Medical Systems. Device class: 2.
Clearance details
- Applicant
- Rita Medical Systems
- 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
- Special
- Location
- Mountain View, CA, US
Recent devices under product code GEI
view allMore clearances from Rita Medical Systems
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 →
Recalls naming K992693
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K992693.
Data sourced from openFDA. This site is unofficial and independent of the FDA.