FDA product code HHK: Curette, Suction, Endometrial (And Accessories)
HHK is the FDA product code for curette, suction, endometrial (and accessories). It is a Class II device, regulated under 21 CFR 884.1175 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 42 510(k) submissions under HHK, 2 in the last five years, from 36 different applicants. The average 510(k) review took 111 days (median 83); 171 days on average over the last three years. FDA has posted 3 recalls for HHK devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Curette, Suction, Endometrial (And Accessories) |
| Device class | Class II |
| Regulation | 21 CFR 884.1175 |
| 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 HHK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 2 | 106 |
| 2024 | 1 | 224 |
| 2025 | 1 | 118 |
Compare with all 510(k) review times · Search every HHK clearance
Top HHK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Crossbay Medical | 2 | 2020-08-05 |
| Milex Products, Inc. | 2 | 2000-06-15 |
| Ri Mos. S.R.L. | 2 | 1999-10-26 |
| Select Medical Systems, Inc. | 2 | 1998-03-23 |
| Pioneer Medical, Inc. | 2 | 1992-03-04 |
31 more applicants have HHK clearances. See the full list in Caduvo.
Most recent HHK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251882 | Gcmedica Enterprise Ltd.(Wuxi) | Uterine Aspiration Set | 2025-10-16 | 118 |
| K240434 | Li Medical Corporation , Ltd. | RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) | 2024-09-25 | 224 |
| K201952 | Crossbay Medical | CrossGlide ETS Plus | 2020-08-05 | 22 |
| K192534 | Crossbay Medical | CrossBay Endometrial Tissue Sampler (ETS) | 2020-03-25 | 191 |
| K102847 | Jiangsu Suyun Medical Materials Co., Ltd. | DISPOSABLE ENDOMETRIAL SUCTION CURETTE | 2011-04-14 | 197 |
Recalls for HHK devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-09-16.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code HHK?
HHK is the FDA product code for curette, suction, endometrial (and accessories). It is a Class II device, regulated under 21 CFR 884.1175 and reviewed by the Obstetrics and Gynecology panel.
What device class is HHK?
Class II, regulation 21 CFR 884.1175. Typical premarket route: 510(k).
How long does a 510(k) take for product code HHK?
Across 42 cleared submissions the average was 111 days from receipt to decision (median 83).
Which companies have the most HHK clearances?
Crossbay Medical (2); Milex Products, Inc. (2); Ri Mos. S.R.L. (2); Select Medical Systems, Inc. (2); Pioneer Medical, Inc. (2).
Have HHK devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2022-09-16.
Next steps
- Run an FDA pathway report with predicate devices for product code HHK
- Run a recall and safety report across every HHK manufacturer
- Watch product code HHK 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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