Bioderm Medical Hydrogel Island Dressing
FDA 510(k) K951166 · Bioderm, Inc.
510(k) numberK951166
Submission
- Device name
- Bioderm Medical Hydrogel Island Dressing
- Applicant
- Bioderm, Inc.
Wheaton, IL, US - Received
- March 14, 1995
- Decision date
- June 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NAE – Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4022
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K083721 | Modification to ZenievaNAE · Special | River'S Edge Pharmaceuticals, LLC | 01/08/2009SE |
| K082865 | Modification to ZenievaNAE · Special | Gorbec Pharmaceutical Services, Inc. | 10/23/2008SE |
| K073246 | ZenievaNAE · Traditional | Gorbec Pharmaceutical Services, Inc. | 07/23/2008SE |
| K992094 | Giltech Plus Hydrogel Skin DressingNAE · Traditional | Giltech Plus, Inc. | 09/17/1999SE |
| K991061 | Dermaphylyx Calcium Alginate Wound DressingNAE · Traditional | Dermaphylyx, Inc. | 06/28/1999SE |
| K972646 | Ad-Heal Hydrogel Dressing, Various SizesNAE · Traditional | Ludlow Technical Products | 08/21/1997SE |
| K971597 | Comfeel Purilon GEL,15G(3900)/COMFEEL Purilon GEL,25G(3903)NAE · Traditional | Coloplast Corp. | 07/29/1997SE |
| K962352 | Hydrogel Skin DressingNAE · Traditional | North American Sterilization & Packaging Co. | 08/02/1996SE |
| K952945 | Aquaflo Hydrogel Wound Dressing & PackerNAE · Traditional | Sherwood Medical Co. | 08/23/1995SN |
| K950412 | Curagel Hydrogel Wound DressingNAE · Traditional | Kendall Healthcare Products Co. Div.Of Tyco Health | 03/24/1995SE |
More from Kendall Healthcare Products Co. Div.Of Tyco Health
| 510(k) | Device | Decision |
|---|---|---|
| K990955 | Modification Of:Bioderm Foam Wound DressingKMF · Traditional | 05/18/1999SE |
| K982778 | Bioderm Foam Wound DressingKMF · Traditional | 10/21/1998SE |
| K982939 | BTF Thin Film Wound DressingMGP · Traditional | 10/13/1998SE |
| K980451 | Bioderm Calcium Alginate DressingKMF · Traditional | 04/09/1998SN |
| K973429 | Bioderm Foam Wound DressingKMF · Traditional | 12/01/1997SN |
| K963950 | Bioderm Eid Male External Incontinence DeviceEXI · Traditional | 01/10/1997SE |
| K963602 | Bioderm PVP Foam Wound DressingKMF · Traditional | 10/30/1996SE |
| K951842 | Bioderm Medical Transparent Film DressingMGP · Traditional | 06/12/1995SE |
| K950685 | Bioderm Medical Hydrocolloid Wound DressingKMF · Traditional | 06/09/1995SE |
| K950619 | Bioderm Medical Foam Wound DressingKMF · Traditional | 04/25/1995SE |
Questions and answers
When was Bioderm Medical Hydrogel Island Dressing cleared by the FDA?
Bioderm Medical Hydrogel Island Dressing (K951166) received a 510(k) decision of Substantially Equivalent on June 21, 1995, 99 days after the submission was received.
What is the product code of K951166?
The FDA product code is NAE – Dressing, Wound, Hydrogel Without Drug And/Or Biologic, a Class I (low risk) device regulated under 21 CFR 878.4022.