FDA product code QEC: Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree
QEC is the FDA product code for forceps, biopsy, electric surgical hemostasis within tracheobronchial tree. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under QEC. The average 510(k) review took 382 days (median 382).
Definition
An endoscopic electrosurgical forceps and accessories used with an endoscope to electrosurgically collect tissue for biopsy and to perform electrosurgical hemostasis within the tracheobronchial tree
Classification
| Field | Value |
|---|---|
| Device name | Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree |
| Device class | Class II |
| Regulation | 21 CFR 876.4300 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for QEC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 382 |
Compare with all 510(k) review times · Search every QEC clearance
Top QEC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus Medical Systems Corp. | 1 | 2018-11-30 |
Most recent QEC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K173495 | Olympus Medical Systems Corp. | Single Use Hot Biopsy Forceps FD-231 | 2018-11-30 | 382 |
Recalls for QEC devices
openFDA lists no recalls for product code QEC.
Frequently asked questions
What is FDA product code QEC?
QEC is the FDA product code for forceps, biopsy, electric surgical hemostasis within tracheobronchial tree. It is a Class II device, regulated under 21 CFR 876.4300 and reviewed by the Anesthesiology panel.
What device class is QEC?
Class II, regulation 21 CFR 876.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code QEC?
Across 1 cleared submissions the average was 382 days from receipt to decision (median 382).
Which companies have the most QEC clearances?
Olympus Medical Systems Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QEC
- Run a recall and safety report across every QEC manufacturer
- Watch product code QEC 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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