Mentor Expander Mammary Prosthesis
FDA 510(k) K844813 · Mentor Corp.
510(k) numberK844813
Submission
- Device name
- Mentor Expander Mammary Prosthesis
- Applicant
- Mentor Corp.
Goleta, CA, US - Received
- December 11, 1984
- Decision date
- May 10, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LCJ – Tissue Expander And Accessories
- Device class
- Unclassified
- Implant
- Yes
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|---|---|---|---|
| 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 |
More from Allergan
| 510(k) | Device | Decision |
|---|---|---|
| K130813 | Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue…LCJ · Special | 04/11/2013SE |
| K062421 | Mentor Resterilizable Gel Breast Implant SizerMRD · Traditional | 10/10/2006SE |
| K053414 | Mentor Novasilk MeshOTP · Traditional | 12/27/2005SE |
| K053296 | Mentor Aris Suprapubic Surgical KitOTN · Traditional | 12/15/2005SE |
| K052440 | Mentor Self-Cath Hydrogel Intermittent CatheterEZD · Special | 10/11/2005SE |
| K050008 | Mentor Self-Cath Hydrogel Intermittent CatheterEZD · Traditional | 06/03/2005SE |
| K050148 | Mentor Aris Trans-Obturator Tape and Surgical KitOTN · Traditional | 03/09/2005SE |
| K042851 | Mentor Obtape Trans-Obturator Surgical KitOTN · Special | 11/09/2004SE |
| K040959 | Mentor Genesis Penile ProsthesisFAE · Traditional | 10/29/2004SE |
| K031767 | Mentor Obtape Trans-Obturator TapeOTN · Traditional | 07/17/2003SE |
Questions and answers
When was Mentor Expander Mammary Prosthesis cleared by the FDA?
Mentor Expander Mammary Prosthesis (K844813) received a 510(k) decision of Substantially Equivalent on May 10, 1985, 150 days after the submission was received.
What is the product code of K844813?
The FDA product code is LCJ – Tissue Expander And Accessories, a Unclassified device.