Product code DWO
- Device name
- Needle, Biopsy, Cardiovascular
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K933364 | PROMED BIOPSY NEEDLE | Vlv Associates, Inc. | 1994-02-15 |
| K921418 | ULTRA-CORE BIOPSY NEEDLES | Medical Device Technologies, Inc. | 1992-06-19 |
| K913815 | AUTOMATED BIOPSY DEVICE, MODIFICATION | Hart Enterprises, Inc. | 1991-10-30 |
| K890925 | MANAN BONE MARROW BIOPSY NEEDLE | Manan Medical Products, Inc. | 1989-04-11 |
| K885145 | MEDSURG GREENE NEEDLE | Medsurg Industries, Inc. | 1989-03-14 |
| K885149 | NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE | Hart Enterprises, Inc. | 1989-01-26 |
| K882013 | SOFT TISSUE BIOPSY DEVICE | Ocean Medical Products, Ltd. | 1988-06-15 |
| K874585 | ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE | Angiomed U.S., Inc. | 1987-12-02 |
| K872597 | FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE | Dianon Systems, Inc. | 1987-07-28 |
| K853312 | ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES | Argon Medical Corp. | 1985-09-12 |
| K820269 | RNG SERIES ULTRASOUND NEEDLE/CATH. GDS | CIVCO Medical Instruments Co., Inc. | 1982-03-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00884450681190 | Preston™ | Merit Medical Systems, Inc. | 2026-08-21 |
| G635212005 | MAMAWIRE | HISTO S.A. | 2024-05-17 |
| G635911810Y1 | MAMAWIRE FIX | HISTO S.A. | 2024-05-17 |
| G635911810DY1 | MAMAWIRE FIX | HISTO S.A. | 2024-05-17 |
| G635911810DB1 | MAMAWIRE FIX | HISTO S.A. | 2024-05-17 |
| G635911810D1 | MAMAWIRE FIX | HISTO S.A. | 2024-05-17 |
| G635911810B1 | MAMAWIRE FIX | HISTO S.A. | 2024-05-17 |
| G635911810 | MAMAWIRE FIX | HISTO S.A. | 2024-05-17 |
| G635312015 | MAMAWIRE PLUS | HISTO S.A. | 2024-05-17 |
| G635312013 | MAMAWIRE PLUS | HISTO S.A. | 2024-05-17 |
| G635312010 | MAMAWIRE PLUS | HISTO S.A. | 2024-05-17 |
| G635312007 | MAMAWIRE PLUS | HISTO S.A. | 2024-05-17 |
| G635312005 | MAMAWIRE PLUS | HISTO S.A. | 2024-05-17 |
| G635212015 | MAMAWIRE | HISTO S.A. | 2024-05-17 |
| G635212013 | MAMAWIRE | HISTO S.A. | 2024-05-17 |
| G635212012 | MAMAWIRE | HISTO S.A. | 2024-05-17 |
| G635212010 | MAMAWIRE | HISTO S.A. | 2024-05-17 |
| G635212007 | MAMAWIRE | HISTO S.A. | 2024-05-17 |
| G635312012 | MAMAWIRE PLUS | HISTO S.A. | 2024-05-17 |
| 08056138585782 | PenBone | M.D.L. S.R.L. | 2021-05-14 |
| 08056138585775 | PenBone | M.D.L. S.R.L. | 2021-05-14 |
| 08056138585768 | PenBone | M.D.L. S.R.L. | 2021-05-14 |
| 08052440105380 | PressTo | M.D.L. S.R.L. | 2021-04-26 |
| 08032986358921 | Illy | M.D.L. S.R.L. | 2017-04-13 |
| 08052440105274 | PickUp | M.D.L. S.R.L. | 2017-03-30 |
| 08052440105298 | PickUp | M.D.L. S.R.L. | 2017-03-30 |
| 08032986359003 | Illy | M.D.L. S.R.L. | 2017-01-05 |
| 08032986359034 | Illy | M.D.L. S.R.L. | 2017-01-05 |
| 08052440105229 | Harvest | M.D.L. S.R.L. | 2017-01-05 |
| 08032986358976 | Illy | M.D.L. S.R.L. | 2017-01-05 |