FDA product code DWO: Needle, Biopsy, Cardiovascular
DWO is the FDA product code for needle, biopsy, cardiovascular. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 11 510(k) submissions under DWO, from 10 different applicants. The average 510(k) review took 65 days (median 46). FDA has posted 9 recalls for DWO devices.
Classification
| Field | Value |
|---|---|
| Device name | Needle, Biopsy, Cardiovascular |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DWO clearance
Top DWO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hart Enterprises, Inc. | 2 | 1991-10-30 |
| Vlv Associates, Inc. | 1 | 1994-02-15 |
| Medical Device Technologies, Inc. | 1 | 1992-06-19 |
| Manan Medical Products, Inc. | 1 | 1989-04-11 |
| Medsurg Industries, Inc. | 1 | 1989-03-14 |
5 more applicants have DWO clearances. See the full list in Caduvo.
Most recent DWO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K933364 | Vlv Associates, Inc. | PROMED BIOPSY NEEDLE | 1994-02-15 | 221 |
| K921418 | Medical Device Technologies, Inc. | ULTRA-CORE BIOPSY NEEDLES | 1992-06-19 | 87 |
| K913815 | Hart Enterprises, Inc. | AUTOMATED BIOPSY DEVICE, MODIFICATION | 1991-10-30 | 65 |
| K890925 | Manan Medical Products, Inc. | MANAN BONE MARROW BIOPSY NEEDLE | 1989-04-11 | 46 |
| K885145 | Medsurg Industries, Inc. | MEDSURG GREENE NEEDLE | 1989-03-14 | 89 |
Recalls for DWO devices
9 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-08-05.
| Year | Recalls |
|---|---|
| 2018 | 7 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code DWO?
DWO is the FDA product code for needle, biopsy, cardiovascular. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is DWO?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DWO?
Across 11 cleared submissions the average was 65 days from receipt to decision (median 46).
Which companies have the most DWO clearances?
Hart Enterprises, Inc. (2); Vlv Associates, Inc. (1); Medical Device Technologies, Inc. (1); Manan Medical Products, Inc. (1); Medsurg Industries, Inc. (1).
Have DWO devices been recalled?
Yes: 9 product recalls across 3 recall events; the most recent began 2021-08-05.
Next steps
- Run an FDA pathway report with predicate devices for product code DWO
- Run a recall and safety report across every DWO manufacturer
- Watch product code DWO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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