Circulon System Step 1
FDA 510(k) K951022 · Convatec, A Division of E.R. Squibb & Sons
510(k) numberK951022
Submission
- Device name
- Circulon System Step 1
- Applicant
- Convatec, A Division of E.R. Squibb & Sons
Princeton, NJ, US - Received
- March 7, 1995
- Decision date
- June 12, 1995
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K926063 | Per-Q-Cath Dressing Change TrayMCY · Traditional | Gesco Intl., Inc. | 06/07/1993SEKD |
More from Gesco Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K090254 | Silver Impregnated Hydrofiber Dressing Reinforced with Nylon (Flat)FRO · Traditional | 09/04/2009SE |
| K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingFRO · Traditional | 05/02/2008SE |
| K063271 | Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated…FRO · Traditional | 04/16/2007SE |
| K013814 | Absorbent Antimicrobial Wound DressingFRO · Traditional | 06/21/2002SE |
| K990964 | Signadress Duoderm DressingKGN · Traditional | 05/18/1999SE |
| K984388 | Ha Absorbent Wound DressingKGN · Traditional | 03/03/1999SE |
| K980720 | Nonwoven PadKMF · Traditional | 04/15/1998SE |
| K980382 | Non-Woven CompressKMF · Traditional | 03/09/1998SN |
| K974823 | Nonwoven DressingKMF · Traditional | 02/20/1998SN |
| K974205 | Knitted Wound Dressing-Standard, WCL and RibbonKMF · Traditional | 02/06/1998SE |
Questions and answers
When was Circulon System Step 1 cleared by the FDA?
Circulon System Step 1 (K951022) received a 510(k) decision of Unknown on June 12, 1995, 97 days after the submission was received.
What is the product code of K951022?
The FDA product code is MCY – Wound Dressing Kit, a Class II (moderate risk) device regulated under 21 CFR 880.5075.