Envisan Paste
FDA 510(k) K874553 · Marion Laboratories, Inc.
510(k) numberK874553
Submission
- Device name
- Envisan Paste
- Applicant
- Marion Laboratories, Inc.
Kansas City, MI, US - Received
- November 4, 1987
- Decision date
- December 18, 1987
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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 |
| K905688 | Cutinova HydroKOZ · Traditional | Beiersdorf, Inc. | 04/01/1991SE |
| 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 |
More from Smith & Nephew United, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883391 | Polymer Adhesive BandageNAD · Traditional | 03/23/1989SN |
| K875182 | Modified Labeling for Toxi-Lab THC ScreenDKE · Traditional | 07/05/1988SE |
| K875181 | Modified Labeling for Toxi-Lab Broad Spectrum · Traditional | 05/27/1988SE |
| K874554 | Enviclusive (TM)NAD · Traditional | 03/11/1988SE |
| K874552 | Envisan PadKOZ · Traditional | 01/22/1988SN |
| K874551 | Envinet(Tm)EFQ · Traditional | 01/22/1988SN |
| K870864 | Culturette Brand CDT Clostridium Difficile TestLLH · Traditional | 04/14/1987SE |
| K863485 | Modification of Cdt(Tm) Clostridium TestLLH · Traditional | 09/17/1986SE |
| K862123 | Biosphere Anaerobic Environmental DeviceKZJ · Traditional | 06/16/1986SE |
| K853073 | Culturette Brand 10-MINUTE Group a Strep I.D.GTZ · Traditional | 08/01/1985SE |
Questions and answers
When was Envisan Paste cleared by the FDA?
Envisan Paste (K874553) received a 510(k) decision of Substantially Equivalent for Some Indications on December 18, 1987, 44 days after the submission was received.
What is the product code of K874553?
The FDA product code is KOZ – Beads, Hydrophilic, For Wound Exudate Absorption, a Class I (low risk) device regulated under 21 CFR 878.4018.