FDA product code HHT: Spatula, Cervical, Cytological
HHT is the FDA product code for spatula, cervical, cytological. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 73 510(k) submissions under HHT, from 58 different applicants. The average 510(k) review took 163 days (median 80).
Classification
| Field | Value |
|---|---|
| Device name | Spatula, Cervical, Cytological |
| Device class | Class II |
| Regulation | 21 CFR 884.4530 |
| 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 HHT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 442 |
| 2019 | 1 | 268 |
Compare with all 510(k) review times · Search every HHT clearance
Top HHT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rovers Medical Devices B.V. | 3 | 2005-02-02 |
| Intl. Cytobrush, Inc. | 3 | 1989-12-11 |
| Surgipath Medical Industries, Inc. | 3 | 1988-07-19 |
| Orifice Medical AB | 2 | 1999-06-29 |
| Andwin Scientific | 2 | 1998-12-11 |
53 more applicants have HHT clearances. See the full list in Caduvo.
Most recent HHT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K182049 | Excell Company, LLC | exCellerator Cervical Collection Device | 2019-04-25 | 268 |
| K153128 | Kolplast CI SA | Kolplast Cervical Sample Collection Kit | 2017-01-13 | 442 |
| K141057 | Ningbo Hls Medical Products Co., Ltd. | DISPOSABLE CERVICAL BRUSH | 2015-05-14 | 385 |
| K111681 | Puritan Medical Products Company, LLC | HISTOBRUSH | 2012-01-19 | 218 |
| K083012 | Otto Bock Pur Life Science GmbH | PAPCONE | 2009-04-09 | 182 |
Recalls for HHT devices
openFDA lists no recalls for product code HHT.
Frequently asked questions
What is FDA product code HHT?
HHT is the FDA product code for spatula, cervical, cytological. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is HHT?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k).
How long does a 510(k) take for product code HHT?
Across 73 cleared submissions the average was 163 days from receipt to decision (median 80).
Which companies have the most HHT clearances?
Rovers Medical Devices B.V. (3); Intl. Cytobrush, Inc. (3); Surgipath Medical Industries, Inc. (3); Orifice Medical AB (2); Andwin Scientific (2).
Next steps
- Run an FDA pathway report with predicate devices for product code HHT
- Run a recall and safety report across every HHT manufacturer
- Watch product code HHT 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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