Softxil
FDA 510(k) K171851 · Bistool
510(k) numberK171851
Submission
- Device name
- Softxil
- Applicant
- Bistool
Seoul, KR - Received
- June 21, 2017
- Decision date
- March 16, 2018
- 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
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 |
| 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 |
| K052504 | Gluteal Implant, Models RND 5-X, TRD 6-XMIB · Traditional | Implantech Associates, Inc. | 11/04/2005SE |
Questions and answers
When was Softxil cleared by the FDA?
Softxil (K171851) received a 510(k) decision of Substantially Equivalent on March 16, 2018, 268 days after the submission was received.
What is the product code of K171851?
The FDA product code is MIB – Elastomer, Silicone Block, a Class II (moderate risk) device regulated under 21 CFR 874.3620.