STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLARTECH RADIOFREQUENCY GENERATOR, MODEL 1025A-230— 510(k) K994173
Substantially EquivalentStellartech Research Corp.
FDA 510(k) clearance K994173 for STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLARTECH RADIOFREQUENCY GENERATOR, MODEL 1025A-230, Substantially Equivalent on 2000-01-20. Applicant: Stellartech Research Corp.. Device class: 2.
Clearance details
- Applicant
- Stellartech Research Corp.
- 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
- Abbreviated
- Location
- Sunnyvale, CA, US
Recent devices under product code GEI
view allMore clearances from Stellartech Research Corp.
view all- K061544 — STELLARTECH 100 COAGULATION SYSTEM
- K050831 — STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A
- K042909 — STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A
- K041383 — STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230
- K040240 — STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
Adverse 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.