FDA product code HCE: Clamp, Carotid Artery
HCE is the FDA product code for clamp, carotid artery. It is a Class II device, regulated under 21 CFR 882.5175 and reviewed by the Neurology panel. FDA has cleared 2 510(k) submissions under HCE, from 2 different applicants. The average 510(k) review took 60 days (median 60).
Classification
| Field | Value |
|---|---|
| Device name | Clamp, Carotid Artery |
| Device class | Class II |
| Regulation | 21 CFR 882.5175 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every HCE clearance
Top HCE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Codman & Shurtleff, Inc. | 1 | 1987-03-06 |
| New England Surgical Instrument Corp. | 1 | 1981-09-24 |
Most recent HCE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K870399 | Codman & Shurtleff, Inc. | SELVERSTONE CLAMP SALIBI CLAMP | 1987-03-06 | 32 |
| K811821 | New England Surgical Instrument Corp. | CAROTID ARTERY CLAMP & TOOLS | 1981-09-24 | 87 |
Recalls for HCE devices
openFDA lists no recalls for product code HCE.
Frequently asked questions
What is FDA product code HCE?
HCE is the FDA product code for clamp, carotid artery. It is a Class II device, regulated under 21 CFR 882.5175 and reviewed by the Neurology panel.
What device class is HCE?
Class II, regulation 21 CFR 882.5175. Typical premarket route: 510(k).
How long does a 510(k) take for product code HCE?
Across 2 cleared submissions the average was 60 days from receipt to decision (median 60).
Which companies have the most HCE clearances?
Codman & Shurtleff, Inc. (1); New England Surgical Instrument Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HCE
- Run a recall and safety report across every HCE manufacturer
- Watch product code HCE 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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