MCY — Wound Dressing Kit Class II
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 |
| K912116 | medical device inspection co | PRESSURE SORE MANAGEMENT KIT | October 18, 1991 |
| K913480 | catalina biomedical | WOUND CARE TRAY A | 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 |