FLYNN TISSUE PROBE AND BLUNT DISSECTOR— 510(k) K910713

Substantially Equivalent

Marlo Surgical Technology

FDA 510(k) clearance K910713 for FLYNN TISSUE PROBE AND BLUNT DISSECTOR, Substantially Equivalent on 1991-03-21. Applicant: Marlo Surgical Technology.

Clearance details

Applicant
Marlo Surgical Technology
Product code
Code HET
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Willoughby, OH, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code HET

product code HET
Malfunction
10,504
Total
10,504

Source: openFDA MAUDE database, through . 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.