FDA product code HDJ: Scissors, Umbilical
HDJ is the FDA product code for scissors, umbilical. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under HDJ. The average 510(k) review took 21 days (median 21).
Classification
| Field | Value |
|---|---|
| Device name | Scissors, Umbilical |
| Device class | Class I |
| Regulation | 21 CFR 884.4520 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HDJ clearance
Top HDJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kinetic Medical Products | 1 | 1989-02-13 |
Most recent HDJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890389 | Kinetic Medical Products | UMBILICAL SCISSORS | 1989-02-13 | 21 |
Recalls for HDJ devices
openFDA lists no recalls for product code HDJ.
Frequently asked questions
What is FDA product code HDJ?
HDJ is the FDA product code for scissors, umbilical. It is a Class I device, regulated under 21 CFR 884.4520 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDJ?
Class I, regulation 21 CFR 884.4520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HDJ?
Across 1 cleared submissions the average was 21 days from receipt to decision (median 21).
Which companies have the most HDJ clearances?
Kinetic Medical Products (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HDJ
- Run a recall and safety report across every HDJ manufacturer
- Watch product code HDJ 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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