Wet Chamber
FDA 510(k) K020781 · Kinetic Concepts, Inc.
510(k) numberK020781
Submission
- Device name
- Wet Chamber
- Applicant
- Kinetic Concepts, Inc.
San Antonio, TX, US - Received
- March 11, 2002
- Decision date
- May 6, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K964534 | Otosilk Otological Graft DressingNAD · Traditional | Boston Medical Products, Inc. | 04/09/1997SE |
More from Boston Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K050261 | V.A.C. Granufoam Silver Protection DressingOMP · Traditional | 05/26/2005SE |
| K041642 | V.A.C. Granufoam Silver DressingOMP · Traditional | 01/25/2005SE |
| K032310 | Mini V.A.C., V.A.C. Freedom, V.A.C. AtsOMP · Traditional | 10/10/2003SE |
| K022011 | V.A.C. Abdominal DressingFTL · Traditional | 02/26/2003SE |
| K021500 | Vacuum Assisted ClosureOMP · Traditional | 12/20/2002SE |
| K021501 | V.A.C. Instillamat (Vacuum Assisted Closure InstillamatOMP · Traditional | 12/02/2002SE |
| K992448 | V.A.C. PlusOMP · Traditional | 01/18/2000SE |
| K972176 | Home Care Bead BedINX · Traditional | 01/16/1998SE |
| K972549 | SimpulseFNM · Traditional | 11/18/1997SE |
| K955243 | BariairFNM · Traditional | 10/23/1997SE |
Questions and answers
When was Wet Chamber cleared by the FDA?
Wet Chamber (K020781) received a 510(k) decision of Substantially Equivalent on May 6, 2002, 56 days after the submission was received.
What is the product code of K020781?
The FDA product code is NAD – Dressing, Wound, Occlusive, a Class I (low risk) device regulated under 21 CFR 878.4020.