FDA product code CBG: Spreader, Cuff
CBG is the FDA product code for spreader, cuff. It is a Class I device, regulated under 21 CFR 868.5760 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under CBG. The average 510(k) review took 37 days (median 37).
Classification
| Field | Value |
|---|---|
| Device name | Spreader, Cuff |
| Device class | Class I |
| Regulation | 21 CFR 868.5760 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every CBG clearance
Top CBG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kalajian Ent. | 1 | 1987-03-19 |
Most recent CBG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K870600 | Kalajian Ent. | SOFT EAR STETHOSCOPE | 1987-03-19 | 37 |
Recalls for CBG devices
openFDA lists no recalls for product code CBG.
Frequently asked questions
What is FDA product code CBG?
CBG is the FDA product code for spreader, cuff. It is a Class I device, regulated under 21 CFR 868.5760 and reviewed by the Anesthesiology panel.
What device class is CBG?
Class I, regulation 21 CFR 868.5760. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CBG?
Across 1 cleared submissions the average was 37 days from receipt to decision (median 37).
Which companies have the most CBG clearances?
Kalajian Ent. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CBG
- Run a recall and safety report across every CBG manufacturer
- Watch product code CBG 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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