Curagel Hydrogel Wound Dressing
FDA 510(k) K950412 · Kendall Healthcare Products Co. Div.Of Tyco Health
510(k) numberK950412
Submission
- Device name
- Curagel Hydrogel Wound Dressing
- Applicant
- Kendall Healthcare Products Co. Div.Of Tyco Health
Mansfield, MA, US - Received
- January 31, 1995
- Decision date
- March 24, 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
Other 510(k)s with product code NAE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K951166 | Bioderm Medical Hydrogel Island DressingNAE · Traditional | Bioderm, Inc. | 06/21/1995SE |
More from Bioderm, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973763 | Kendall Curity Iodoform Packing StripEFQ · Traditional | 12/31/1997SE |
| K973511 | Kendall Curity Petrolatum GauzeFRO · Traditional | 12/16/1997SN |
| K973507 | Kendall Xeroform Petrolatum Dressing (6311,6312,6313,6314,6315,6316,6317)FRO · Traditional | 12/15/1997SN |
| K973619 | Kendall Curity Non-Adhering DressingKMF · Traditional | 12/10/1997SN |
| K973509 | Kendall Curasorb ZN + MG Alginate Wound DressingKMF · Traditional | 12/04/1997SN |
| K973546 | Kendall Fast-Cath Pre Lubricated Urethral CatheterEZD · Traditional | 11/07/1997SE |
| K970266 | Kendall Hydrophilic Powder Wound DressingKGN · Traditional | 04/23/1997SN |
| K963446 | Kendall Dual Lumen CatheterMPB · Traditional | 03/18/1997SE |
| K964899 | Kendall Curity Ureteral CatheterEYB · Traditional | 02/07/1997SE |
| K964519 | Curity Thoracentesis TrayGCX · Traditional | 12/20/1996SE |
Questions and answers
When was Curagel Hydrogel Wound Dressing cleared by the FDA?
Curagel Hydrogel Wound Dressing (K950412) received a 510(k) decision of Substantially Equivalent on March 24, 1995, 52 days after the submission was received.
What is the product code of K950412?
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.