FDA product code HFE: Brush, Endometrial
HFE is the FDA product code for brush, endometrial. It is a Class II device, regulated under 21 CFR 884.1100 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 9 510(k) submissions under HFE, 1 in the last five years, from 8 different applicants. The average 510(k) review took 290 days (median 163); 163 days on average over the last three years. FDA has posted 1 recall for HFE devices.
Classification
| Field | Value |
|---|---|
| Device name | Brush, Endometrial |
| Device class | Class II |
| Regulation | 21 CFR 884.1100 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HFE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 84 |
| 2024 | 1 | 163 |
Compare with all 510(k) review times · Search every HFE clearance
Top HFE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cook Ob/Gyn | 2 | 1995-02-13 |
| Utepreva, LLC | 1 | 2024-08-14 |
| Cook Incorporated | 1 | 2017-05-24 |
| Post Oak Innovations, Inc. | 1 | 2012-06-18 |
| Cook Urological, Inc. | 1 | 2008-11-07 |
3 more applicants have HFE clearances. See the full list in Caduvo.
Most recent HFE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240595 | Utepreva, LLC | Utepreva Endometrial Sampler (UP01) | 2024-08-14 | 163 |
| K170603 | Cook Incorporated | Tao Brush I.U.M.C. Endometrial Sampler | 2017-05-24 | 84 |
| K112763 | Post Oak Innovations, Inc. | MATRIXBRUSH ENDOMETRIAL SAMPLER | 2012-06-18 | 270 |
| K082066 | Cook Urological, Inc. | TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER | 2008-11-07 | 108 |
| K941298 | Cook Ob/Gyn | IUMC ENDOMETRIAL SAMPLER | 1995-02-13 | 333 |
Recalls for HFE devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-04-02.
Frequently asked questions
What is FDA product code HFE?
HFE is the FDA product code for brush, endometrial. It is a Class II device, regulated under 21 CFR 884.1100 and reviewed by the Obstetrics and Gynecology panel.
What device class is HFE?
Class II, regulation 21 CFR 884.1100. Typical premarket route: 510(k).
How long does a 510(k) take for product code HFE?
Across 9 cleared submissions the average was 290 days from receipt to decision (median 163).
Which companies have the most HFE clearances?
Cook Ob/Gyn (2); Utepreva, LLC (1); Cook Incorporated (1); Post Oak Innovations, Inc. (1); Cook Urological, Inc. (1).
Have HFE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2009-04-02.
Next steps
- Run an FDA pathway report with predicate devices for product code HFE
- Run a recall and safety report across every HFE manufacturer
- Watch product code HFE 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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