Intrasite Hydrocolloid Wound Dressing
FDA 510(k) K911660 · Smith & Nephew United, Inc.
510(k) numberK911660
Submission
- Device name
- Intrasite Hydrocolloid Wound Dressing
- Applicant
- Smith & Nephew United, Inc.
Largo, FL, US - Received
- April 12, 1991
- Decision date
- June 17, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MGP – Dressing, Wound And Burn, Occlusive
- Device class
- Unclassified
Other 510(k)s with product code MGP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K012997 | Collatek FoamMGP · Traditional | Biocore Medical Technologies, Inc. | 10/25/2001SE |
| K012995 | Collatek SheetMGP · Traditional | Biocore Medical Technologies, Inc. | 10/25/2001SE |
| K001508 | Laserskin DressingMGP · Traditional | Fidia Advanced Biopolymers Srl | 07/25/2001SE |
| K990079 | Fastseal Chest Wound DressingMGP · Traditional | Greenfield Medical Technologies, Inc. | 12/23/1999SE |
| K991214 | Simplicare Transparent Wound DressingMGP · Traditional | Hollister, Inc. | 10/14/1999SE |
| K992302 | Dermaphylyx Skin Protectors, Protect It Skin ProtectorsMGP · Traditional | Dermaphylyx, Inc. | 09/14/1999SE |
| K992005 | Giltech Plus Transparent DressingMGP · Traditional | Giltech Plus, Inc. | 09/03/1999SE |
| K990875 | Dermaphylyx Film Wound Dressing and Healian Film Wound DressingMGP · Traditional | Dermaphylyx, Inc. | 05/27/1999SN |
| K990438 | Dermaflex Wound Dressing, Dermaflex Foam Wound Dressing, Healiaflex Wound Dressing…MGP · Traditional | Dermaphylyx, Inc. | 03/25/1999SE |
| K984371 | Mepitel Non Adherent Silicone DressingMGP · Traditional | Molnlycke Health Care, Inc. | 03/03/1999SE |
More from Molnlycke Health Care, 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 |
| K942748 | IntrasiteNAE · Traditional | 06/29/1994SN |
| 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 |
Questions and answers
When was Intrasite Hydrocolloid Wound Dressing cleared by the FDA?
Intrasite Hydrocolloid Wound Dressing (K911660) received a 510(k) decision of Substantially Equivalent on June 17, 1991, 66 days after the submission was received.
What is the product code of K911660?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.