ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL)— 510(k) K940505

Substantially Equivalent

Uresil Corp.

FDA 510(k) clearance K940505 for ARTICULATING LAPAROSCOPIC RETRACOTOR (URESIL), Substantially Equivalent on 1994-06-21. Applicant: Uresil Corp..

Clearance details

Applicant: Uresil Corp.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1994-02-03
Decision date: 1994-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, IL, 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.