Motiva Flora SmoothSilk Tissue Expander
FDA 510(k) K211676 · Motiva USA, LLC
510(k) numberK211676
Submission
- Device name
- Motiva Flora SmoothSilk Tissue Expander
- Applicant
- Motiva USA, LLC
Santa Barbara, CA, US - Received
- June 1, 2021
- Decision date
- October 13, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCJ – Tissue Expander And Accessories
- Device class
- Unclassified
- Implant
- Yes
Other 510(k)s with product code LCJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254126 | Natrelle 133S Tissue ExpandersLCJ · Special | AbbVie | 01/16/2026SE |
| K242963 | MENTOR PliaForm Breast Tissue Expander w/ Suture TabsLCJ · Traditional | Mentor Worldwide, LLC | 04/24/2025SE |
| K243836 | Mentor CPX 4 PLUS Enhance Breast Tissue ExpanderLCJ · Special | Mentor Worldwide, LLC | 01/12/2025SE |
| K241918 | MENTOR CPX4 PLUS Enhance Breast Tissue ExpanderLCJ · Special | Mentor Worldwide, LLC | 08/02/2024SE |
| K214124 | AlloX2 Pro Tissue ExpandersLCJ · Traditional | Sientra, Inc. | 06/08/2023SE |
| K221127 | Sientra, inc. PortfinderLCJ · Traditional | Sientra, Inc. | 05/10/2023SE |
| K180826 | Natrelle 133 Plus MICROCELL Tissue ExpanderLCJ · Traditional | Allergan | 12/21/2018SE |
| K182335 | CPX 4 Breast Tissue Expander with Smooth SurfaceLCJ · Special | Mentor Worldwide, LLC | 09/25/2018SE |
| K182054 | Natrelle 133S Tissue ExpanderLCJ · Special | Allergan | 08/29/2018SE |
| K161483 | Unger Quad InjectorLCJ · Traditional | Stradis Healthcare | 10/31/2016SE |
More from Stradis Healthcare
| 510(k) | Device | Decision |
|---|---|---|
| K183163 | Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant MatrixMRD · Traditional | 02/05/2019SE |
Questions and answers
When was Motiva Flora SmoothSilk Tissue Expander cleared by the FDA?
Motiva Flora SmoothSilk Tissue Expander (K211676) received a 510(k) decision of Substantially Equivalent on October 13, 2023, 864 days after the submission was received.
What is the product code of K211676?
The FDA product code is LCJ – Tissue Expander And Accessories, a Unclassified device.