Mcghan Longterm Mammary Expander/Gel-Saline Design
FDA 510(k) K864184 · Mcghan Medical Corp.
510(k) numberK864184
Submission
- Device name
- Mcghan Longterm Mammary Expander/Gel-Saline Design
- Applicant
- Mcghan Medical Corp.
Santa Barbara, CA, US - Received
- October 27, 1986
- Decision date
- December 24, 1986
- 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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| 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 |
|---|---|---|
| K873476 | Mini-Motor Hand Engine & Access. Dermabrasion BursGEY · Traditional | 09/11/1987SE |
| K873475 | Micro-Torque Hand Engine & Access. Dermabra. BursGEY · Traditional | 09/11/1987SE |
| K870754 | Mcghan Tissue Expander Fill SystemLCJ · Traditional | 03/31/1987SE |
| K864185 | Mcghan Longterm Mammary Expander, RTV DesignLCJ · Traditional | 12/24/1986SE |
| K862203 | Mcghan Magna-Site(Tm) Tissue ExpanderLCJ · Traditional | 07/23/1986SE |
| K854794 | Mcghan Integral Valve Tissue ExpanderLCJ · Traditional | 12/24/1985SE |
| K853014 | Mcghan Tissue Expander Fill KitLCJ · Traditional | 09/18/1985SE |
| K843704 | Mcghan Tissue ExpanderLCJ · Traditional | 10/31/1984SE |
| K781087 | Medical Grade Silicone Elastomer TubingFPK · Traditional | 11/22/1978SE |
| K781700 | Ionotphoretic ApplicatorKTB · Traditional | 11/03/1978SE |
Questions and answers
When was Mcghan Longterm Mammary Expander/Gel-Saline Design cleared by the FDA?
Mcghan Longterm Mammary Expander/Gel-Saline Design (K864184) received a 510(k) decision of Substantially Equivalent on December 24, 1986, 58 days after the submission was received.
What is the product code of K864184?
The FDA product code is LCJ – Tissue Expander And Accessories, a Unclassified device.