FDA product code HDP: Elevator, Uterine
HDP is the FDA product code for elevator, uterine. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 4 510(k) submissions under HDP, from 4 different applicants. The average 510(k) review took 141 days (median 138).
Classification
| Field | Value |
|---|---|
| Device name | Elevator, Uterine |
| 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 |
Compare with all 510(k) review times · Search every HDP clearance
Top HDP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Conkin Surgical Instruments , Ltd. | 1 | 1998-07-09 |
| Clinical Innovations, Inc. | 1 | 1998-03-02 |
| Zinnanti Surgical Instruments, Inc. | 1 | 1988-09-29 |
| Bivona Medical Technologies | 1 | 1982-07-30 |
Most recent HDP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974801 | Conkin Surgical Instruments , Ltd. | SINGLE CHANNEL BALLOON CANNULA | 1998-07-09 | 199 |
| K974563 | Clinical Innovations, Inc. | COLPO CUP CVC-2000 | 1998-03-02 | 87 |
| K882054 | Zinnanti Surgical Instruments, Inc. | HYSTERO KIT | 1988-09-29 | 136 |
| K820672 | Bivona Medical Technologies | HASSON BUEC-3 | 1982-07-30 | 141 |
Recalls for HDP devices
openFDA lists no recalls for product code HDP.
Frequently asked questions
What is FDA product code HDP?
HDP is the FDA product code for elevator, uterine. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDP?
Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k).
How long does a 510(k) take for product code HDP?
Across 4 cleared submissions the average was 141 days from receipt to decision (median 138).
Which companies have the most HDP clearances?
Conkin Surgical Instruments , Ltd. (1); Clinical Innovations, Inc. (1); Zinnanti Surgical Instruments, Inc. (1); Bivona Medical Technologies (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HDP
- Run a recall and safety report across every HDP manufacturer
- Watch product code HDP 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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