SOPRANO CRYO-THERAPY SYSTEM— 510(k) K980393
Substantially EquivalentGynecare Innovation Center
FDA 510(k) clearance K980393 for SOPRANO CRYO-THERAPY SYSTEM, Substantially Equivalent on 1998-05-01. Applicant: Gynecare Innovation Center. Device class: 2.
Clearance details
- Applicant
- Gynecare Innovation Center
- 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
- Sunnyvale, CA, US
Recent devices under product code GEI
view allMore clearances from Gynecare Innovation Center
view all- K971305 — FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM
- K964441 — FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
- K964892 — FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)
- K963872 — FEMRX MORCELLATOR SYSTEM
- K962506 — [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]
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.