FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE— 510(k) K915857

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K915857 for FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE, Substantially Equivalent on 1994-03-11. Applicant: Olympus Corp..

Clearance details

Applicant: Olympus Corp.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1991-12-27
Decision date: 1994-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

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Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.