Intrasite
FDA 510(k) K942748 · Smith & Nephew United, Inc.
510(k) numberK942748
Submission
- Device name
- Intrasite
- Applicant
- Smith & Nephew United, Inc.
Largo, FL, US - Received
- June 10, 1994
- Decision date
- June 29, 1994
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K963096 | Allevyn Hydro Poly Dressing ND All Trac DressingKMF · Traditional | 10/25/1996SE |
| K961775 | Profore Four-Layer Bandage System KitEFQ · Traditional | 07/16/1996SE |
| K945330 | Allevyn AdhesiveKMF · Traditional | 02/09/1995SN |
| K943619 | Cavi-Care Conforming Foam DressingKMF · Traditional | 08/19/1994SN |
| K935705 | Allevyn Island Wound DressingNAE · Traditional | 02/15/1994SE |
| K935803 | Cica-Care Silicone Gel SheetMDA · Traditional | 02/03/1994SE |
| K932263 | Solosite Dermal Wound GelMGQ · Traditional | 10/01/1993SE |
| K926508 | Intrasite GelNAE · Traditional | 07/13/1993SE |
| K922897 | StrappalKGX · Traditional | 09/15/1992SE |
| K914147 | Allevlyn Wound Dressing, ModificationKMF · Traditional | 02/03/1992SE |
Questions and answers
When was Intrasite cleared by the FDA?
Intrasite (K942748) received a 510(k) decision of Substantially Equivalent for Some Indications on June 29, 1994, 19 days after the submission was received.
What is the product code of K942748?
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.