G-Tube Dressing Change Tray
FDA 510(k) K905123 · Continental Medical Laboratories, Inc.
510(k) numberK905123
Submission
- Device name
- G-Tube Dressing Change Tray
- Applicant
- Continental Medical Laboratories, Inc.
Waterford, WI, US - Received
- November 14, 1990
- Decision date
- March 27, 1991
- Decision
- Substantially Equivalent (SESE)
- 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 |
|---|---|---|
| K964827 | Prod. No. 01-132 - Suture Removal KitMCZ · Traditional | 02/14/1997SE |
| K963234 | Staple Removal KitGDT · Traditional | 10/21/1996SE |
| K963443 | Prod. No. 02-031 - Laceration TrayLRO · Traditional | 10/17/1996SE |
| K962078 | Tracheostomy Cleaning Tray W/Suction CatheterJOH · Traditional | 10/11/1996SESK |
| K954728 | Prod No. 01-1694 - 4X4 Foam DressingKMF · Traditional | 09/23/1996SN |
| K962073 | Urethral Catheterization Tray/Universal Urethral Cath TrayFCM · Traditional | 06/21/1996SE |
| K952335 | Wound Care Management KitsLYY · Traditional | 06/14/1995SE |
Questions and answers
When was G-Tube Dressing Change Tray cleared by the FDA?
G-Tube Dressing Change Tray (K905123) received a 510(k) decision of Substantially Equivalent on March 27, 1991, 133 days after the submission was received.
What is the product code of K905123?
The FDA product code is MCY – Wound Dressing Kit, a Class II (moderate risk) device regulated under 21 CFR 880.5075.