DeviceClearance

K101440

Substantially Equivalent

GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012

Applicant
Generic Medical Devices, Inc.
Product code
OTN
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Ocean Shores, WA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OTN

product code OTN
Injury
6,630
Total
6,630

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.