FDA product code KAG: Holder, Speculum, Ent
KAG is the FDA product code for holder, speculum, ent. It is a Class I device, regulated under 21 CFR 878.1800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under KAG, from 2 different applicants. The average 510(k) review took 80 days (median 80).
Classification
| Field | Value |
|---|---|
| Device name | Holder, Speculum, Ent |
| Device class | Class I |
| Regulation | 21 CFR 878.1800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KAG clearance
Top KAG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E K Ind., Inc. | 1 | 1984-09-21 |
| Cardiac Pacemakers, Inc. | 1 | 1983-01-08 |
Most recent KAG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842931 | E K Ind., Inc. | DRABKIN REAGENT | 1984-09-21 | 58 |
| K822857 | Cardiac Pacemakers, Inc. | CPI PRINTER | 1983-01-08 | 103 |
Recalls for KAG devices
openFDA lists no recalls for product code KAG.
Frequently asked questions
What is FDA product code KAG?
KAG is the FDA product code for holder, speculum, ent. It is a Class I device, regulated under 21 CFR 878.1800 and reviewed by the General and Plastic Surgery panel.
What device class is KAG?
Class I, regulation 21 CFR 878.1800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KAG?
Across 2 cleared submissions the average was 80 days from receipt to decision (median 80).
Which companies have the most KAG clearances?
E K Ind., Inc. (1); Cardiac Pacemakers, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KAG
- Run a recall and safety report across every KAG manufacturer
- Watch product code KAG 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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