Sil-K
FDA 510(k) K914701 · Degania Silicone , Ltd.
510(k) numberK914701
Submission
- Device name
- Sil-K
- Applicant
- Degania Silicone , Ltd.
Emek Hayarden, IL - Received
- October 18, 1991
- Decision date
- January 31, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MDA – Elastomer, Silicone, For Scar Management
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4025
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K112131 | Neodyne DressingMDA · Traditional | Neodyne Biosciences, Inc. | 09/29/2011SE |
| K111733 | Coreleader Scar-DimmerMDA · Traditional | Coreleader Biotech Co., Ltd. | 09/22/2011SE |
| K083718 | Beau RX Scar Care GelMDA · Traditional | Beau RX Solutions, LLC | 01/26/2009SE |
| K053481 | Kelo-Cote SprayMDA · Traditional | Advanced Bio-Technologies, Inc. | 04/14/2006SE |
| K041704 | Newgel and Newgel Plus EMDA · Traditional | Newmedical Technology, Inc. | 10/17/2005SE |
| K040307 | Hanson Scar AdeMDA · Traditional | Hanson Medical, Inc. | 08/12/2004SE |
| K024057 | Curad Scar TherapyMDA · Traditional | Beiersdorf, Inc. | 06/18/2003SE |
| K024160 | Neosporin Scar SolutionMDA · Traditional | Warner-Lambert Co. | 03/17/2003SE |
| K023678 | Dimisil Scar GelMDA · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 01/23/2003SE |
| K023136 | Oleeva FabricMDA · Special | Bio Med Sciences, Inc. | 10/16/2002SE |
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Questions and answers
When was Sil-K cleared by the FDA?
Sil-K (K914701) received a 510(k) decision of Substantially Equivalent on January 31, 1992, 105 days after the submission was received.
What is the product code of K914701?
The FDA product code is MDA – Elastomer, Silicone, For Scar Management, a Class I (low risk) device regulated under 21 CFR 878.4025.