MCY — Wound Dressing Kit Class II
FDA product code MCY covers "Wound Dressing Kit", a Class II medical device regulated under 21 CFR 880.5075. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MCY
- Device Class
- Class II
- Regulation Number
- 880.5075
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General Hospital
- Implant
- No
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K970721 | johnson and johnson medical | DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM | March 21, 1997 |
| K963719 | grand medical products | CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY | November 27, 1996 |
| K960585 | suncoast medical products | WOUND CARE COMPRESSION SYSTEM (WCCS) | April 26, 1996 |
| K952334 | busse hospital disposables | DRESSING CHANGE TRAY | July 14, 1995 |
| K951022 | convatec, a division of e.r. squibb and sons | CIRCULON SYSTEM STEP 1 | June 12, 1995 |
| K951021 | convatec, a division of e.r. squibb and sons | CIRCULON SYSTEM STEP 2 | June 12, 1995 |
| K951476 | ethicon | E-PACK PROCEDURE KITS | May 23, 1995 |
| K931932 | medsurg industries | DRESSING CHANGE TRAY-MODIFIED | August 27, 1993 |
| K924690 | surgipro central | VARIOUS NON-STERILE CUSTOM TRAYS/KITS | July 16, 1993 |
| K923905 | kit pak | WOUND DRESSING KIT | July 2, 1993 |
| K925021 | customed | TPN TRAY (STERILE) | June 7, 1993 |
| K926063 | gesco intl | PER-Q-CATH DRESSING CHANGE TRAY | June 7, 1993 |
| K921347 | medi-flex hospital products | CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER | January 8, 1993 |
| K913480 | catalina biomedical | WOUND CARE TRAY A | October 18, 1991 |
| K912116 | medical device inspection co | PRESSURE SORE MANAGEMENT KIT | October 18, 1991 |
| K912684 | great west medical equipment | HOME MEDICAL KIT - FOR LITTLE HURTS | October 15, 1991 |
| K913479 | catalina biomedical | WOUND CARE TRAY B | October 8, 1991 |
| K912232 | jobst institute | ULCERCARE | August 14, 1991 |
| K912117 | medical device inspection co | LACERATION TRAY | August 9, 1991 |
| K910363 | megadyne medical products | MEGA DRESSING CHANGE KIT | March 28, 1991 |