[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]— 510(k) K962506

Substantially Equivalent

Gynecare Innovation Center

FDA 510(k) clearance K962506 for [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)], Substantially Equivalent on 1996-09-16. Applicant: Gynecare Innovation Center.

Clearance details

Applicant: Gynecare Innovation Center
Product code: Code FJL
Advisory panel: Gastroenterology, Urology
Date received: 1996-06-27
Decision date: 1996-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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.