Pre-Formed Silicone Block

FDA 510(k) K223051 · International Medical Devices, Inc.

Substantially Equivalent

510(k) numberK223051

Submission

Device name
Pre-Formed Silicone Block
Applicant
International Medical Devices, Inc.
Beverly Hills, CA, US
Received
September 29, 2022
Decision date
February 3, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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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K200073AugMENTA Penile ImplantMIB · Traditional Augmenta, LLC09/30/2022SE
K220760Pre-Formed Penile Silicone BlockMIB · Traditional International Medical Devices, Inc.05/13/2022SE
K193392BioSiCar Silicone ImplantMIB · Traditional Metalware Technology Corp.07/20/2020SE
K181387Pre-Formed Penile Silicone BlockMIB · Traditional International Medical Devices, Inc.01/23/2019SE
K171851SoftxilMIB · Traditional Bistool03/16/2018SE
K162624Pre-Formed Penile Silicone BlockMIB · Traditional International Medical Devices, Inc.02/01/2017SE
K052505Calf Implant, Model EC17-XMIB · Traditional Implantech Associates, Inc.11/04/2005SE
K052504Gluteal Implant, Models RND 5-X, TRD 6-XMIB · Traditional Implantech Associates, Inc.11/04/2005SE

More from Implantech Associates, Inc.

510(k)DeviceDecision
K220760Pre-Formed Penile Silicone BlockMIB · Traditional 05/13/2022SE
K181387Pre-Formed Penile Silicone BlockMIB · Traditional 01/23/2019SE
K162624Pre-Formed Penile Silicone BlockMIB · Traditional 02/01/2017SE

Questions and answers

When was Pre-Formed Silicone Block cleared by the FDA?

Pre-Formed Silicone Block (K223051) received a 510(k) decision of Substantially Equivalent on February 3, 2023, 127 days after the submission was received.

What is the product code of K223051?

The FDA product code is MIB – Elastomer, Silicone Block, a Class II (moderate risk) device regulated under 21 CFR 874.3620.