Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix
FDA 510(k) clearance K183163 · decided 2019-02-05
Clearance details
- K-number
- K183163
- Device name
- Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix
- Applicant
- Motiva USA, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-11-15
- Decision date
- 2019-02-05
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- MRD
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Motiva SmoothSilk®Round; Round Ergonomix® Silicone Gel-Filled Breast Implants (P230005/S003) | Motiva USA, LLC | 2025-12-17 |
| Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas (P230005/S001) | Motiva USA, LLC | 2024-11-22 |
| Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone Gel-Filled Breas (P230005) | Motiva USA, LLC | 2024-09-26 |