Calf Implant, Model EC17-X
FDA 510(k) K052505 · Implantech Associates, Inc.
510(k) numberK052505
Submission
- Device name
- Calf Implant, Model EC17-X
- Applicant
- Implantech Associates, Inc.
Ventura, CA, US - Received
- September 13, 2005
- Decision date
- November 4, 2005
- 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
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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 |
| K052504 | Gluteal Implant, Models RND 5-X, TRD 6-XMIB · Traditional | Implantech Associates, Inc. | 11/04/2005SE |
More from Implantech Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K200610 | Customized Contour ImplantFWP · Traditional | 12/23/2020SE |
| K191130 | Customized Contour ImplantFWP · Traditional | 08/23/2019SE |
| K172389 | ePTFE-Coated Auricular ImplantFZD · Traditional | 07/18/2018SE |
| K141027 | 3D Eptfe; Anatomical Chin, Curvilinear Chin, Extended Anatomical Chin Implant, Submalar…FWP · Traditional | 07/10/2014SE |
| K071470 | Implantech Eptfe Sheeting, Model Eptfe-XxxFTL · Traditional | 08/31/2007SE |
| K052504 | Gluteal Implant, Models RND 5-X, TRD 6-XMIB · Traditional | 11/04/2005SE |
| K013732 | GelzoneMDA · Traditional | 02/07/2002SE |
| K012419 | Conform Sheeting, Model IgelMDA · Traditional | 10/24/2001SE |
| K002886 | Implantech Composite Facial Implants (Malar, Chin, and Nasal)LZK · Traditional | 11/24/2000SE |
| K973502 | Implantech Conform Binder Submalar ImplantLZK · Traditional | 11/07/1997SE |
Questions and answers
When was Calf Implant, Model EC17-X cleared by the FDA?
Calf Implant, Model EC17-X (K052505) received a 510(k) decision of Substantially Equivalent on November 4, 2005, 52 days after the submission was received.
What is the product code of K052505?
The FDA product code is MIB – Elastomer, Silicone Block, a Class II (moderate risk) device regulated under 21 CFR 874.3620.