Tensoplus Lite
FDA 510(k) K901378 · Smith & Nephew United, Inc.
510(k) numberK901378
Submission
- Device name
- Tensoplus Lite
- Applicant
- Smith & Nephew United, Inc.
Largo, FL, US - Received
- March 22, 1990
- Decision date
- June 12, 1990
- Decision
- Substantially Equivalent (SESE)
- 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 |
|---|---|---|
| K963096 | Allevyn Hydro Poly Dressing ND All Trac DressingKMF · Traditional | 10/25/1996SE |
| K961775 | Profore Four-Layer Bandage System KitEFQ · Traditional | 07/16/1996SE |
| K945330 | Allevyn AdhesiveKMF · Traditional | 02/09/1995SN |
| K943619 | Cavi-Care Conforming Foam DressingKMF · Traditional | 08/19/1994SN |
| K942748 | IntrasiteNAE · Traditional | 06/29/1994SN |
| K935705 | Allevyn Island Wound DressingNAE · Traditional | 02/15/1994SE |
| K935803 | Cica-Care Silicone Gel SheetMDA · Traditional | 02/03/1994SE |
| K932263 | Solosite Dermal Wound GelMGQ · Traditional | 10/01/1993SE |
| K926508 | Intrasite GelNAE · Traditional | 07/13/1993SE |
| K922897 | StrappalKGX · Traditional | 09/15/1992SE |
Questions and answers
When was Tensoplus Lite cleared by the FDA?
Tensoplus Lite (K901378) received a 510(k) decision of Substantially Equivalent on June 12, 1990, 82 days after the submission was received.
What is the product code of K901378?
The FDA product code is NAD – Dressing, Wound, Occlusive, a Class I (low risk) device regulated under 21 CFR 878.4020.