Silicone Tissue/Inflatable Tissue Expander
FDA 510(k) K974209 · Specialty Surgical Products, Inc.
510(k) numberK974209
Submission
- Device name
- Silicone Tissue/Inflatable Tissue Expander
- Applicant
- Specialty Surgical Products, Inc.
Hamilton, MT, US - Received
- November 10, 1997
- Decision date
- February 6, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LCJ – Tissue Expander And Accessories
- Device class
- Unclassified
- Implant
- Yes
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| 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 |
|---|---|---|
| K140383 | ALLOX2 Tissue ExpandersLCJ · Traditional | 10/28/2014SE |
| K070303 | Silicone Tissue ExpanderLCJ · Traditional | 06/22/2007SE |
| K984106 | Mammary Sizer, Mammary Prothesis SizerMRD · Traditional | 02/12/1999SE |
| K983015 | Virilis Penile ProsthesisFTQ · Traditional | 02/05/1999SE |
| K982258 | Mammary SizerMRD · Traditional | 09/08/1998SE |
| K982065 | Sterile Silicone External Wound CoverMIB · Traditional | 08/12/1998SE |
| K982067 | Magnetic Port Silicone Tissue ExpanderLCJ · Traditional | 07/13/1998SE |
| K974653 | Silicone Elastomer SheetingMIB · Traditional | 03/13/1998SE |
| K974654 | Silicone BlocksMIB · Traditional | 02/24/1998SE |
| K973656 | Disposable Silicone Epistaxis CatheterEMX · Traditional | 11/18/1997SE |
Questions and answers
When was Silicone Tissue/Inflatable Tissue Expander cleared by the FDA?
Silicone Tissue/Inflatable Tissue Expander (K974209) received a 510(k) decision of Substantially Equivalent on February 6, 1998, 88 days after the submission was received.
What is the product code of K974209?
The FDA product code is LCJ – Tissue Expander And Accessories, a Unclassified device.