FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDSURG ARTHROGRAM TRAY
K Number: K854292
·
Decision Nov 26, 1985
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
41
Review Days
32
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Basic Information
- Device Name
- MEDSURG ARTHROGRAM TRAY
- K Number
- K854292
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medsurg Industries, Inc.
- Date Received
- October 25, 1985
- Decision Date
- November 26, 1985
- Product Code
- LRO
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
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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 |
| K931932 | DRESSING CHANGE TRAY-MODIFIED | Aug 27, 1993 | Unknown |
| K914037 | MEDSURG O.R. PROCEDURE TRAY | Jun 22, 1993 | Unknown |
| K914036 | MEDSURG LAPAROSCOPY TRAY | Mar 18, 1992 | Substantially Equivalent |