Silicone Blocks
FDA 510(k) K974654 · Specialty Surgical Products, Inc.
510(k) numberK974654
Submission
- Device name
- Silicone Blocks
- Applicant
- Specialty Surgical Products, Inc.
Hamilton, MT, US - Received
- December 15, 1997
- Decision date
- February 24, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MIB – Elastomer, Silicone Block
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
Other 510(k)s with product code MIB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241150 | MISTI Silicone ImplantMIB · Traditional | Keosan Trading Co. | 07/24/2024SE |
| K223051 | Pre-Formed Silicone BlockMIB · Traditional | International Medical Devices, Inc. | 02/03/2023SE |
| K222748 | ShiNeo Silicone ImplantMIB · Traditional | Shineo Technology Co., Ltd. | 12/23/2022SE |
| K200073 | AugMENTA Penile ImplantMIB · Traditional | Augmenta, LLC | 09/30/2022SE |
| K220760 | Pre-Formed Penile Silicone BlockMIB · Traditional | International Medical Devices, Inc. | 05/13/2022SE |
| K193392 | BioSiCar Silicone ImplantMIB · Traditional | Metalware Technology Corp. | 07/20/2020SE |
| K181387 | Pre-Formed Penile Silicone BlockMIB · Traditional | International Medical Devices, Inc. | 01/23/2019SE |
| K171851 | SoftxilMIB · Traditional | Bistool | 03/16/2018SE |
| K162624 | Pre-Formed Penile Silicone BlockMIB · Traditional | International Medical Devices, Inc. | 02/01/2017SE |
| K052505 | Calf Implant, Model EC17-XMIB · Traditional | Implantech Associates, Inc. | 11/04/2005SE |
More from Implantech Associates, Inc.
| 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 |
| K974209 | Silicone Tissue/Inflatable Tissue ExpanderLCJ · Traditional | 02/06/1998SE |
| K973656 | Disposable Silicone Epistaxis CatheterEMX · Traditional | 11/18/1997SE |
Questions and answers
When was Silicone Blocks cleared by the FDA?
Silicone Blocks (K974654) received a 510(k) decision of Substantially Equivalent on February 24, 1998, 71 days after the submission was received.
What is the product code of K974654?
The FDA product code is MIB – Elastomer, Silicone Block, a Class II (moderate risk) device regulated under 21 CFR 874.3620.