STRYKER OPERATING LAPAROSCOPE— 510(k) K943100

Substantially Equivalent

Stryker Endoscopy

FDA 510(k) clearance K943100 for STRYKER OPERATING LAPAROSCOPE, Substantially Equivalent on 1995-08-10. Applicant: Stryker Endoscopy.

Clearance details

Applicant: Stryker Endoscopy
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1994-06-29
Decision date: 1995-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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.