GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012— 510(k) K101440
Substantially EquivalentGeneric Medical Devices, Inc.
FDA 510(k) clearance K101440 for GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012, Substantially Equivalent on 2010-06-18. Applicant: Generic Medical Devices, Inc..
Clearance details
- Applicant
- Generic Medical Devices, Inc.
- Product code
- Code OTN
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Ocean Shores, WA, US
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.