IMAGYN MICROLAP INTRODUCER— 510(k) K943810

Substantially Equivalent

Imagyn Medical, Inc.

FDA 510(k) clearance K943810 for IMAGYN MICROLAP INTRODUCER, Substantially Equivalent on 1995-01-26. Applicant: Imagyn Medical, Inc..

Clearance details

Applicant: Imagyn Medical, Inc.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1994-08-05
Decision date: 1995-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, CA, 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.