Curity Vented Dressing System
FDA 510(k) K915635 · Kendall Healthcare Products Co. Div.Of Tyco Health
510(k) numberK915635
Submission
- Device name
- Curity Vented Dressing System
- Applicant
- Kendall Healthcare Products Co. Div.Of Tyco Health
Mansfield, MA, US - Received
- December 17, 1991
- Decision date
- January 31, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| 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 Curity Vented Dressing System cleared by the FDA?
Curity Vented Dressing System (K915635) received a 510(k) decision of Substantially Equivalent on January 31, 1992, 45 days after the submission was received.
What is the product code of K915635?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.