Hysorb Wound Dressing
FDA 510(k) K921502 · Kingston Technologies, Inc.
510(k) numberK921502
Submission
- Device name
- Hysorb Wound Dressing
- Applicant
- Kingston Technologies, Inc.
Dayton, NJ, US - Received
- March 31, 1992
- Decision date
- September 29, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KMF – Bandage, Liquid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5090
- Specialty
- General Hospital
Other 510(k)s with product code KMF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241916 | TearRepair Liquid Skin ProtectantKMF · Traditional | Optmed, Inc. | 09/27/2024SE |
| K182733 | Rochal Bioshield Silicone FilmKMF · Traditional | Rochal Industries, LLC | 06/27/2019SE |
| K171148 | Aleo BME Liquid BandageKMF · Traditional | Aleo Bme, Inc. | 01/12/2018SE |
| K153571 | Cavilon Advanced High Endurance Skin ProtectantKMF · Traditional | 3M Healthcare | 08/23/2016SE |
| K160684 | Atteris No-Sting Skin ProtectantKMF · Traditional | Rochal Industries, LLC | 07/26/2016SE |
| K131384 | Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid BandageKMF · Traditional | Kericure, Inc. | 08/07/2014SE |
| K133443 | Marathon No Sting Liquid Skin ProtectantKMF · Traditional | Advanced Medical Solutions (Plymouth), Ltd. | 07/10/2014SE |
| K120059 | Liquid BandageKMF · Traditional | Chesson Laboratory Associates, Inc. | 05/17/2012SE |
| K092712 | Skin Barrier FilmKMF · Traditional | Lodestar Products, Inc. | 02/23/2010SE |
| K083087 | EcocelKMF · Traditional | Polichem S.A | 08/07/2009SE |
More from Polichem S.A
| 510(k) | Device | Decision |
|---|---|---|
| K935232 | Hydrotorque Guide WireDQX · Traditional | 07/20/1994SE |
| K940814 | Hydro-M(Tm) Wound GelMGQ · Traditional | 05/12/1994SE |
| K940738 | Kti Hy-Q(Tm) Wound DressingKMF · Traditional | 05/06/1994SN |
| K925660 | Kti Transparent Wound DressingMGP · Traditional | 04/20/1993SE |
| K882157 | Panamex(Tm) Ureteral StentFAD · Traditional | 08/02/1988SE |
Questions and answers
When was Hysorb Wound Dressing cleared by the FDA?
Hysorb Wound Dressing (K921502) received a 510(k) decision of Substantially Equivalent on September 29, 1992, 182 days after the submission was received.
What is the product code of K921502?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.