FDA product code DWZ: Device, Biopsy, Endomyocardial
DWZ is the FDA product code for device, biopsy, endomyocardial. It is a Class II device, regulated under 21 CFR 870.4075 and reviewed by the Cardiovascular panel. FDA has cleared 23 510(k) submissions under DWZ, 1 in the last five years, from 16 different applicants. The average 510(k) review took 98 days (median 84); 33 days on average over the last three years. FDA has posted 1 recall for DWZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Biopsy, Endomyocardial |
| Device class | Class II |
| Regulation | 21 CFR 870.4075 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DWZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 85 |
| 2025 | 1 | 33 |
Compare with all 510(k) review times · Search every DWZ clearance
Top DWZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cordis Corp. | 5 | 1994-01-06 |
| Boston Scientific Corp | 2 | 2000-02-28 |
| Portlyn Corp. | 2 | 1995-07-27 |
| Annex Medical, Inc. | 2 | 1992-10-21 |
| Fehling Instruments GmbH | 1 | 2025-09-30 |
11 more applicants have DWZ clearances. See the full list in Caduvo.
Most recent DWZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252722 | Fehling Instruments GmbH | Biopsy Forceps | 2025-09-30 | 33 |
| K170726 | Fehling Instruments GmbH & Co. KG | Biopsy Forceps | 2017-06-02 | 85 |
| K072051 | Scholten Surgical Instruments, Inc. | NOVATOME, MODEL: SU101-50 | 2007-10-03 | 69 |
| K010473 | Atc Technologies, Inc. | SPARROWHAWK DISPOSABLE | 2001-06-06 | 106 |
| K000409 | Boston Scientific Corp | MODIFICATION TO T-REX BIOPSY FORCEPS | 2000-02-28 | 20 |
Recalls for DWZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-04-12.
Frequently asked questions
What is FDA product code DWZ?
DWZ is the FDA product code for device, biopsy, endomyocardial. It is a Class II device, regulated under 21 CFR 870.4075 and reviewed by the Cardiovascular panel.
What device class is DWZ?
Class II, regulation 21 CFR 870.4075. Typical premarket route: 510(k).
How long does a 510(k) take for product code DWZ?
Across 23 cleared submissions the average was 98 days from receipt to decision (median 84).
Which companies have the most DWZ clearances?
Cordis Corp. (5); Boston Scientific Corp (2); Portlyn Corp. (2); Annex Medical, Inc. (2); Fehling Instruments GmbH (1).
Have DWZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-04-12.
Next steps
- Run an FDA pathway report with predicate devices for product code DWZ
- Run a recall and safety report across every DWZ manufacturer
- Watch product code DWZ 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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