FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDSURG GREENE NEEDLE
K Number: K885145
·
Decision Mar 14, 1989
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
10
Applicant Total
41
Review Days
89
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Basic Information
- Device Name
- MEDSURG GREENE NEEDLE
- K Number
- K885145
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medsurg Industries, Inc.
- Date Received
- December 15, 1988
- Decision Date
- March 14, 1989
- Product Code
- DWO
- 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 |
|---|---|---|---|
| DWO | Needle, Biopsy, Cardiovascular | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWO), ordered by most recent decision date.
PROMED BIOPSY NEEDLE
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ULTRA-CORE BIOPSY NEEDLES
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MANAN BONE MARROW BIOPSY NEEDLE
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NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE
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SOFT TISSUE BIOPSY DEVICE
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·General, Plastic Surgery
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 |