LAPAROSCOPY SET— 510(k) K924485

Name: FDA 510(k) clearance K924485
Creator: U.S. Food and Drug Administration
Published: 1994-03-09

Substantially Equivalent

Owens Precision Systems, Inc.

FDA 510(k) clearance K924485 for LAPAROSCOPY SET, Substantially Equivalent on 1994-03-09. Applicant: Owens Precision Systems, Inc.. Device class: 2.

Clearance details

Applicant: Owens Precision Systems, Inc.
Product code: Code HET
Device class: Class 2
Regulation: 21 CFR 884.1720
Advisory panel: Obstetrics/Gynecology
Date received: 1992-09-03
Decision date: 1994-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oak Creek, WI, US

Download summary PDF View on FDA.gov ↗

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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.