FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)— 510(k) K964892

Substantially Equivalent

Gynecare 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.

Clearance details

Applicant: Gynecare Innovation Center
Product code: Code FJL
Advisory panel: Gastroenterology, Urology
Date received: 1996-12-06
Decision date: 1997-02-04
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, 2020-01-01 through 2026-04-23. 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.