Modification to Zenieva
FDA 510(k) K082865 · Gorbec Pharmaceutical Services, Inc.
510(k) numberK082865
Submission
- Device name
- Modification to Zenieva
- Applicant
- Gorbec Pharmaceutical Services, Inc.
Durham, NC, US - Received
- September 29, 2008
- Decision date
- October 23, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| 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
Questions and answers
When was Modification to Zenieva cleared by the FDA?
Modification to Zenieva (K082865) received a 510(k) decision of Substantially Equivalent on October 23, 2008, 24 days after the submission was received.
What is the product code of K082865?
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.