LAPRO-LOADER(TM)— 510(k) K932689

Substantially Equivalent

Surgimark, Inc.

FDA 510(k) clearance K932689 for LAPRO-LOADER(TM), Substantially Equivalent on 1994-04-11. Applicant: Surgimark, Inc..

Clearance details

Applicant: Surgimark, Inc.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1993-06-03
Decision date: 1994-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yakima, WA, 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.