Cutinova Hydro
FDA 510(k) K905688 · Beiersdorf, Inc.
510(k) numberK905688
Submission
- Device name
- Cutinova Hydro
- Applicant
- Beiersdorf, Inc.
Norwalk, CT, US - Received
- December 19, 1990
- Decision date
- April 1, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOZ – Beads, Hydrophilic, For Wound Exudate Absorption
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4018
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code KOZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K905206 | Incare Pinsite DressingKOZ · Traditional | Hollister, Inc. | 04/12/1991SE |
| K905069 | Iodosorb GelKOZ · Traditional | Perstorp AB C/O Robert Joel Slomoff | 01/31/1991SE |
| K904604 | Redi-Release Absorbent DressingKOZ · Traditional | Fountain Pharmaceuticals, Inc. | 01/07/1991SE |
| K903645 | Dermasorb Wound Contact Layer DressingKOZ · Traditional | Convatec, A Division of E.R. Squibb & Sons | 11/21/1990SE |
| K896828 | Bioclusive(R) Absorbent DressingKOZ · Traditional | Johnson & Johnson International | 11/21/1990SE |
| K904412 | Allevyn Dressing Claims ChangeKOZ · Traditional | Smith & Nephew United, Inc. | 10/23/1990SN |
| K901876 | Intrasite Cavity Wound Dressing (Label Revision)KOZ · Traditional | Smith & Nephew United, Inc. | 06/28/1990SN |
| K896176 | Exusorb(Tm) Dry/Wet DressingKOZ · Traditional | Controlled Therapeutics Corp. | 11/24/1989SE |
| K895354 | Intrasite Cavity Wound DressingKOZ · Traditional | Smith & Nephew United, Inc. | 11/07/1989SN |
| K874552 | Envisan PadKOZ · Traditional | Marion Laboratories, Inc. | 01/22/1988SN |
More from Marion Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K090921 | Anti-Embolism Stockings, Models 71055-00000-02, 71057-00000-02, 71059-00000-02…DWL · Traditional | 12/18/2009SE |
| K032463 | Curad Silver BandageFRO · Traditional | 02/10/2004SE |
| K032462 | Curad Silver Active Gel BandageFRO · Traditional | 02/10/2004SE |
| K024057 | Curad Scar TherapyMDA · Traditional | 06/18/2003SE |
| K022645 | CuradKMF · Traditional | 11/05/2002SE |
| K952526 | Cutinova CavityKMF · Traditional | 08/14/1995SN |
| K943363 | Cutiplast SterilMGP · Traditional | 03/15/1995SE |
| K944581 | Cutinova Thin Wound DressingKMF · Traditional | 12/02/1994SN |
| K935630 | NortaEZL · Traditional | 10/07/1994SE |
| K940378 | Coverlet Adhesive DressingKGX · Traditional | 07/29/1994SN |
Questions and answers
When was Cutinova Hydro cleared by the FDA?
Cutinova Hydro (K905688) received a 510(k) decision of Substantially Equivalent on April 1, 1991, 103 days after the submission was received.
What is the product code of K905688?
The FDA product code is KOZ – Beads, Hydrophilic, For Wound Exudate Absorption, a Class I (low risk) device regulated under 21 CFR 878.4018.