FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
DRESSING CHANGE TRAY-MODIFIED
K Number: K931932
·
Decision Aug 27, 1993
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
23
Applicant Total
41
Review Days
130
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DRESSING CHANGE TRAY-MODIFIED
- K Number
- K931932
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5075
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Medsurg Industries, Inc.
- Date Received
- April 19, 1993
- Decision Date
- August 27, 1993
- Product Code
- MCY
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MCY | Wound Dressing Kit | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MCY), ordered by most recent decision date.
DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY
FDA 510(k)
FDA Class 2
·General Hospital
WOUND CARE COMPRESSION SYSTEM (WCCS)
FDA 510(k)
FDA Class 2
·General Hospital
DRESSING CHANGE TRAY
FDA 510(k)
FDA Class 2
·General Hospital
CIRCULON SYSTEM STEP 1
FDA 510(k)
FDA Class 2
·General Hospital
CIRCULON SYSTEM STEP 2
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Medsurg Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K920780 | MEDSURG INSERTION TRAY | Aug 19, 1994 | Unknown |
| K940175 | MEDSURG STERILE O.R. TOWELS | May 26, 1994 | Substantially Equivalent |
| K934731 | MEDSURG STERILE IMAGING PRODUCTS | Mar 28, 1994 | Substantially Equivalent |
| K925558 | INFILTUBE | Mar 4, 1994 | Substantially Equivalent |
| K934971 | STERILE LAPAROTOMY SPONGES | Feb 7, 1994 | Substantially Equivalent |
| K920421 | MEDSURG MARSHMALLOW TRAY | Dec 13, 1993 | Unknown |
| K920838 | MEDSURG CIRCUMCISION TRAY | Oct 15, 1993 | Substantially Equivalent |
| K914037 | MEDSURG O.R. PROCEDURE TRAY | Jun 22, 1993 | Unknown |
| K914036 | MEDSURG LAPAROSCOPY TRAY | Mar 18, 1992 | Substantially Equivalent |
| K893938 | CONTINUOUS EPIDURAL ANESTHESIA TRAY | Aug 7, 1989 | Substantially Equivalent |