Seare Biomedical Silicone Rods
FDA 510(k) K983630 · Seare Biomedical Corp.
510(k) numberK983630
Submission
- Device name
- Seare Biomedical Silicone Rods
- Applicant
- Seare Biomedical Corp.
Salt Lake City, UT, US - Received
- October 15, 1998
- Decision date
- December 11, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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| 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 |
|---|---|---|
| K983792 | Seare Biomedical Silicone Tissue ExpanderLCJ · Traditional | 12/11/1998SE |
| K983043 | Seare Biomedical Silicone BlockMIC · Traditional | 09/30/1998SE |
| K983041 | Seare Biomedical Silicone SheetingMIB · Traditional | 09/30/1998SE |
| K982763 | Seare Biomedical Malar ImplantsLZK · Traditional | 09/30/1998SE |
| K982762 | Seare Biomedical Pectoralis ImplantMIC · Traditional | 09/30/1998SE |
| K982753 | Seare Biomedical Nasal ImplantsFZE · Traditional | 09/30/1998SE |
| K982752 | Seare Biomedical Chin ImplantsFWP · Traditional | 09/30/1998SE |
Questions and answers
When was Seare Biomedical Silicone Rods cleared by the FDA?
Seare Biomedical Silicone Rods (K983630) received a 510(k) decision of Substantially Equivalent on December 11, 1998, 57 days after the submission was received.
What is the product code of K983630?
The FDA product code is MIB – Elastomer, Silicone Block, a Class II (moderate risk) device regulated under 21 CFR 874.3620.