DWO — Needle, Biopsy, Cardiovascular Class I
FDA product code DWO covers "Needle, Biopsy, Cardiovascular", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DWO
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K933364 | vlv associates | PROMED BIOPSY NEEDLE | February 15, 1994 |
| K921418 | medical device technologies | ULTRA-CORE BIOPSY NEEDLES | June 19, 1992 |
| K913815 | hart enterprises | AUTOMATED BIOPSY DEVICE, MODIFICATION | October 30, 1991 |
| K890925 | manan medical products | MANAN BONE MARROW BIOPSY NEEDLE | April 11, 1989 |
| K885145 | medsurg industries | MEDSURG GREENE NEEDLE | March 14, 1989 |
| K885149 | hart enterprises | NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE | January 26, 1989 |
| K882013 | ocean medical products | SOFT TISSUE BIOPSY DEVICE | June 15, 1988 |
| K874585 | angiomed u.s | ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE | December 2, 1987 |
| K872597 | dianon systems | FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE | July 28, 1987 |
| K853312 | argon medical | ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES | September 12, 1985 |
| K820269 | civco medical instruments co | RNG SERIES ULTRASOUND NEEDLE/CATH. GDS | March 23, 1982 |