Per-Q-Cath Dressing Change Tray
FDA 510(k) K926063 · Gesco Intl., Inc.
510(k) numberK926063
Submission
- Device name
- Per-Q-Cath Dressing Change Tray
- Applicant
- Gesco Intl., Inc.
San Antonio, TX, US - Received
- December 1, 1992
- Decision date
- June 7, 1993
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K954422 | Per-Q-Cath Mid-LineLJS · Traditional | 12/15/1995SE |
| K940953 | Umbili-Cath-SFOS · Traditional | 08/02/1994SE |
| K940870 | Umbili-CathFOS · Traditional | 08/02/1994SE |
| K940952 | Umbili-Cath-S-DlFOS · Traditional | 07/29/1994SE |
| K941672 | Uri-Cath CatheterGBM · Traditional | 05/16/1994SE |
| K941232 | Thora-CathJOL · Traditional | 05/11/1994SE |
| K940871 | Umbili-Cath-PFOS · Traditional | 04/29/1994SE |
| K931989 | Ventri-CathJXG · Traditional | 07/21/1993SE |
| K923591 | Pala-NateBTR · Traditional | 03/16/1993SE |
| K915167 | Gesco Per-Q-Cath Catheter IntroducerDYB · Traditional | 01/27/1992SE |
Questions and answers
When was Per-Q-Cath Dressing Change Tray cleared by the FDA?
Per-Q-Cath Dressing Change Tray (K926063) received a 510(k) decision of Unknown on June 7, 1993, 188 days after the submission was received.
What is the product code of K926063?
The FDA product code is MCY – Wound Dressing Kit, a Class II (moderate risk) device regulated under 21 CFR 880.5075.