BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM— 510(k) K960810

Substantially Equivalent

Marlo Surgical Technology

FDA 510(k) clearance K960810 for BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM, Substantially Equivalent on 1996-10-21. Applicant: Marlo Surgical Technology.

Clearance details

Applicant: Marlo Surgical Technology
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1996-02-28
Decision date: 1996-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Willoughby, OH, US

Download summary PDF View on FDA.gov ↗

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.