FDA product code HAD: Rongeur, Powered
HAD is the FDA product code for rongeur, powered. It is a Class II device, regulated under 21 CFR 882.4845 and reviewed by the Neurology panel. FDA has cleared 3 510(k) submissions under HAD, from 3 different applicants. The average 510(k) review took 86 days (median 96).
Classification
| Field | Value |
|---|---|
| Device name | Rongeur, Powered |
| Device class | Class II |
| Regulation | 21 CFR 882.4845 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HAD clearance
Top HAD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aesculap, Inc. | 1 | 2006-11-21 |
| The Anspach Effort, Inc. | 1 | 2002-10-21 |
| Personal Products Co. | 1 | 1991-08-02 |
Most recent HAD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K062413 | Aesculap, Inc. | AESCULAP PNEUMATIC KERRISON | 2006-11-21 | 96 |
| K022907 | The Anspach Effort, Inc. | ANSPACH POWERED KERRISON SYSTEM (PKS) | 2002-10-21 | 48 |
| K911637 | Personal Products Co. | STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD | 1991-08-02 | 113 |
Recalls for HAD devices
openFDA lists no recalls for product code HAD.
Frequently asked questions
What is FDA product code HAD?
HAD is the FDA product code for rongeur, powered. It is a Class II device, regulated under 21 CFR 882.4845 and reviewed by the Neurology panel.
What device class is HAD?
Class II, regulation 21 CFR 882.4845. Typical premarket route: 510(k).
How long does a 510(k) take for product code HAD?
Across 3 cleared submissions the average was 86 days from receipt to decision (median 96).
Which companies have the most HAD clearances?
Aesculap, Inc. (1); The Anspach Effort, Inc. (1); Personal Products Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HAD
- Run a recall and safety report across every HAD manufacturer
- Watch product code HAD 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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