Duoderm(R) CGF
FDA 510(k) K881050 · Convatec, A Division of E.R. Squibb & Sons
510(k) numberK881050
Submission
- Device name
- Duoderm(R) CGF
- Applicant
- Convatec, A Division of E.R. Squibb & Sons
Princeton, NJ, US - Received
- March 11, 1988
- Decision date
- April 1, 1988
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- NAD – Dressing, Wound, Occlusive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4020
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code NAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254246 | LT Antibacterial Foam with Silver DressingNAD · Traditional | Zhejiang Longterm Medical Technology Co., Ltd. | 09/10/2026SE |
| K102403 | Sam Chest Seal with Vavle; Sam Chest SealNAD · Traditional | Sam Medical Products | 03/03/2011SE |
| K091133 | Aplion Topical Care SystemNAD · Traditional | Aplion Medical,Llc | 05/20/2009SE |
| K072560 | Envela (Hydrohesive Occlusive Dressing)NAD · Traditional | Teikoku Pharma USA, Inc. | 06/17/2008SE |
| K080524 | Centurion Sorbaview OTCNAD · Traditional | Tri-State Hospital Supply Corp. | 04/23/2008SE |
| K060046 | DermastreamNAD · Traditional | Enzysurge , Ltd. | 02/27/2006SE |
| K043063 | Oxyband Wound DressingNAD · Traditional | Oxyband Technologies, Inc. | 03/24/2005SE |
| K020781 | Wet ChamberNAD · Traditional | Kinetic Concepts, Inc. | 05/06/2002SE |
| K990530 | Kerlix MD Antimicrobial Gauze DressingNAD · Traditional | The Kendall Company, L.P. | 01/31/2000SE |
| K990861 | Wound Dressing/Abd Pad, Model #10810NAD · Traditional | Hospital Specialty Co. | 04/12/1999SE |
More from Hospital Specialty Co.
| 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 Duoderm(R) CGF cleared by the FDA?
Duoderm(R) CGF (K881050) received a 510(k) decision of Substantially Equivalent for Some Indications on April 1, 1988, 21 days after the submission was received.
What is the product code of K881050?
The FDA product code is NAD – Dressing, Wound, Occlusive, a Class I (low risk) device regulated under 21 CFR 878.4020.