MCY · Wound Dressing Kit
General Hospital · 21 CFR 880.5075 · Class 2
Overview
| Product Code | MCY |
|---|---|
| Device Name | Wound Dressing Kit |
| Regulation | 21 CFR 880.5075 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K970721 | DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM | Johnson & Johnson Medical, Inc. | Mar 21, 1997 | SN |
| K963719 | CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY | Grand Medical Products | Nov 27, 1996 | SESE |
| K960585 | WOUND CARE COMPRESSION SYSTEM (WCCS) | Suncoast Medical Products, Inc. | Apr 26, 1996 | SESE |
| K952334 | DRESSING CHANGE TRAY | Busse Hospital Disposables, Inc. | Jul 14, 1995 | SESE |
| K951022 | CIRCULON SYSTEM STEP 1 | Convatec, A Division of E.R. Squibb & Sons | Jun 12, 1995 | SESK |
| K951021 | CIRCULON SYSTEM STEP 2 | Convatec, A Division of E.R. Squibb & Sons | Jun 12, 1995 | SESK |
| K951476 | E-PACK PROCEDURE KITS | ETHICON, Inc. | May 23, 1995 | SESK |
| K931932 | DRESSING CHANGE TRAY-MODIFIED | Medsurg Industries, Inc. | Aug 27, 1993 | SEKD |
| K924690 | VARIOUS NON-STERILE CUSTOM TRAYS/KITS | Surgipro Central, Inc. | Jul 16, 1993 | SEKD |
| K923905 | WOUND DRESSING KIT | Kit Pak, Inc. | Jul 2, 1993 | SEKD |
| K926063 | PER-Q-CATH DRESSING CHANGE TRAY | Gesco Intl., Inc. | Jun 7, 1993 | SEKD |
| K925021 | TPN TRAY (STERILE) | Customed, Inc. | Jun 7, 1993 | SEKD |
| K921347 | CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER | Medi-Flex Hospital Products, Inc. | Jan 8, 1993 | SEKD |
| K913480 | WOUND CARE TRAY A | Catalina Biomedical Corp. | Oct 18, 1991 | SESE |
| K912116 | PRESSURE SORE MANAGEMENT KIT | Medical Device Inspection Co., Inc. | Oct 18, 1991 | SESE |
| K912684 | HOME MEDICAL KIT - FOR LITTLE HURTS | Great West Medical Equipment, Inc. | Oct 15, 1991 | SESE |
| K913479 | WOUND CARE TRAY B | Catalina Biomedical Corp. | Oct 8, 1991 | SESE |
| K912232 | ULCERCARE | Jobst Institute, Inc. | Aug 14, 1991 | SESE |
| K912117 | LACERATION TRAY | Medical Device Inspection Co., Inc. | Aug 9, 1991 | SESE |
| K910363 | MEGA DRESSING CHANGE KIT | Megadyne Medical Products, Inc. | Mar 28, 1991 | SESE |
Top Applicants
- Catalina Biomedical Corp. — 2 clearances
- Convatec, A Division of E.R. Squibb & Sons — 2 clearances
- Medical Device Inspection Co., Inc. — 2 clearances
- Busse Hospital Disposables, Inc. — 1 clearance
- Continental Medical Laboratories, Inc. — 1 clearance
