Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue Expanders
FDA 510(k) K130813 · Mentor Corp.
510(k) numberK130813
Submission
- Device name
- Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue Expanders
- Applicant
- Mentor Corp.
Santa Barbara, CA, US - Received
- March 25, 2013
- Decision date
- April 11, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K211676 | Motiva Flora SmoothSilk Tissue ExpanderLCJ · Traditional | Motiva USA, LLC | 10/13/2023SE |
| 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 |
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Questions and answers
When was Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue Expanders cleared by the FDA?
Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue Expanders (K130813) received a 510(k) decision of Substantially Equivalent on April 11, 2013, 17 days after the submission was received.
What is the product code of K130813?
The FDA product code is LCJ – Tissue Expander And Accessories, a Unclassified device.