FDA product code DWQ: Stripper, Vein, External
DWQ is the FDA product code for stripper, vein, external. It is a Class II device, regulated under 21 CFR 870.4885 and reviewed by the Cardiovascular panel. FDA has cleared 8 510(k) submissions under DWQ, 1 in the last five years, from 7 different applicants. The average 510(k) review took 140 days (median 108). FDA has posted 2 recalls for DWQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Stripper, Vein, External |
| Device class | Class II |
| Regulation | 21 CFR 870.4885 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DWQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 202 |
Compare with all 510(k) review times · Search every DWQ clearance
Top DWQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smith & Nephew, Inc. | 2 | 2004-07-22 |
| LeMaitre Vascular, Inc. | 1 | 2022-03-31 |
| Uresil Corp. | 1 | 1991-04-18 |
| Pilling Co. | 1 | 1991-03-01 |
| Aesculap Instruments Corp. | 1 | 1990-02-28 |
2 more applicants have DWQ clearances. See the full list in Caduvo.
Most recent DWQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K212894 | LeMaitre Vascular, Inc. | PhasTIPP | 2022-03-31 | 202 |
| K041453 | Smith & Nephew, Inc. | SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 | 2004-07-22 | 51 |
| K032387 | Smith & Nephew, Inc. | TRIVEX SYSTEM | 2003-10-29 | 86 |
| K905528 | Uresil Corp. | URESIL VALVE CUTTER | 1991-04-18 | 129 |
| K904507 | Pilling Co. | PILLING BRUSH VALVULOTOME | 1991-03-01 | 150 |
Recalls for DWQ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-02-24.
Frequently asked questions
What is FDA product code DWQ?
DWQ is the FDA product code for stripper, vein, external. It is a Class II device, regulated under 21 CFR 870.4885 and reviewed by the Cardiovascular panel.
What device class is DWQ?
Class II, regulation 21 CFR 870.4885. Typical premarket route: 510(k).
How long does a 510(k) take for product code DWQ?
Across 8 cleared submissions the average was 140 days from receipt to decision (median 108).
Which companies have the most DWQ clearances?
Smith & Nephew, Inc. (2); LeMaitre Vascular, Inc. (1); Uresil Corp. (1); Pilling Co. (1); Aesculap Instruments Corp. (1).
Have DWQ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2015-02-24.
Next steps
- Run an FDA pathway report with predicate devices for product code DWQ
- Run a recall and safety report across every DWQ manufacturer
- Watch product code DWQ 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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