Edlich Wound Management Tray
FDA 510(k) K905572 · Sorex Medical
510(k) numberK905572
Submission
- Device name
- Edlich Wound Management Tray
- Applicant
- Sorex Medical
Salt Lake City, UT, US - Received
- December 12, 1990
- Decision date
- March 12, 1991
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
Device classification
- Product code
- MCY – Wound Dressing Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5075
- Specialty
- General Hospital
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Other 510(k)s with product code MCY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970721 | Dyna-Flex Multi-Layer Compression SystemMCY · Traditional | Johnson & Johnson Medical, Inc. | 03/21/1997SN |
| K963719 | Central Line Dressing Change Tray, Tpn/Cvp Dressing Change TrayMCY · Traditional | Grand Medical Products | 11/27/1996SE |
| K960585 | Wound Care Compression System (WCCS)MCY · Traditional | Suncoast Medical Products, Inc. | 04/26/1996SE |
| K952334 | Dressing Change TrayMCY · Traditional | Busse Hospital Disposables, Inc. | 07/14/1995SE |
| K951022 | Circulon System Step 1MCY · Traditional | Convatec, A Division of E.R. Squibb & Sons | 06/12/1995SESK |
| K951021 | Circulon System Step 2MCY · Traditional | Convatec, A Division of E.R. Squibb & Sons | 06/12/1995SESK |
| K951476 | E-Pack Procedure KitsMCY · Traditional | ETHICON, Inc. | 05/23/1995SESK |
| K931932 | Dressing Change Tray-ModifiedMCY · Traditional | Medsurg Industries, Inc. | 08/27/1993SEKD |
| K924690 | Various Non-Sterile Custom Trays/KitsMCY · Traditional | Surgipro Central, Inc. | 07/16/1993SEKD |
| K923905 | Wound Dressing KitMCY · Traditional | Kit Pak, Inc. | 07/02/1993SEKD |
More from Kit Pak, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K923843 | FoglessOCT · Traditional | 03/25/1994SE |
| K913036 | Plume MasterFYD · Traditional | 09/06/1991SE |
| K911070 | Picc-FixKMK · Traditional | 07/05/1991SE |
| K911150 | Sorex Safe-AirGEX · Traditional | 06/28/1991SE |
| K910315 | Picc Insertion Kit/P.I.C. & Picc Exchang Kit/P.E.KLJS · Traditional | 04/05/1991SEKD |
| K903740 | Trach-EzeBSY · Traditional | 12/06/1990SE |
| K902410 | Medical Procedure TrayLDQ · Traditional | 11/20/1990SEKD |
| K885136 | Graft GuardLZM · Traditional | 02/06/1989SE |
Questions and answers
When was Edlich Wound Management Tray cleared by the FDA?
Edlich Wound Management Tray (K905572) received a 510(k) decision of Unknown on March 12, 1991, 90 days after the submission was received.
What is the product code of K905572?
The FDA product code is MCY – Wound Dressing Kit, a Class II (moderate risk) device regulated under 21 CFR 880.5075.