WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM— 510(k) K964436

Substantially Equivalent

Western Surgical Instrument Co.

FDA 510(k) clearance K964436 for WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM, Substantially Equivalent on 1997-01-30. Applicant: Western Surgical Instrument Co..

Clearance details

Applicant: Western Surgical Instrument Co.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1996-11-05
Decision date: 1997-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, 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.