Pre-Formed Penile Silicone Block— 510(k) K220760
Substantially EquivalentInternational Medical Devices, Inc.
FDA 510(k) clearance K220760 for Pre-Formed Penile Silicone Block, Substantially Equivalent on 2022-05-13. Applicant: International Medical Devices, Inc..
Clearance details
- Applicant
- International Medical Devices, Inc.
- Product code
- Code MIB
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beverly Hills, CA, US
Adverse events under product code MIB
product code MIB- Injury
- 146
- Total
- 146
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.