5 MM IRRIGATION/ASPIRATION FIBER PROBE— 510(k) K902258

Name: FDA 510(k) clearance K902258
Creator: U.S. Food and Drug Administration
Published: 1990-09-19

Substantially Equivalent

Hgm Medical Laser Systems, Inc.

FDA 510(k) clearance K902258 for 5 MM IRRIGATION/ASPIRATION FIBER PROBE, Substantially Equivalent on 1990-09-19. Applicant: Hgm Medical Laser Systems, Inc.. Device class: 2.

Clearance details

Applicant: Hgm Medical Laser Systems, Inc.
Product code: Code HET
Device class: Class 2
Regulation: 21 CFR 884.1720
Advisory panel: Obstetrics/Gynecology
Date received: 1990-05-21
Decision date: 1990-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, 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.