FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)— 510(k) K964892
Substantially EquivalentGynecare Innovation Center
FDA 510(k) clearance K964892 for FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY), Substantially Equivalent on 1997-02-04. Applicant: Gynecare Innovation Center. Device class: 2.
Clearance details
- Applicant
- Gynecare Innovation Center
- Product code
- Product code FJL
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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Adverse events under product code FJL
product code FJL- Death
- 2
- Total
- 2
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.