FDA product code KTG: Knife, Ent
KTG is the FDA product code for knife, ent. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 5 510(k) submissions under KTG. The average 510(k) review took 31 days (median 32).
Classification
| Field | Value |
|---|---|
| Device name | Knife, Ent |
| Device class | Class I |
| Regulation | 21 CFR 874.4420 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KTG clearance
Top KTG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 5 | 1982-08-30 |
Most recent KTG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822280 | Kelleher Corp. | ENT KNIFE HANDLES | 1982-08-30 | 32 |
| K822205 | Kelleher Corp. | KNIVES, ENT | 1982-08-30 | 38 |
| K822279 | Kelleher Corp. | LANCETS FOR EAR SURGERY | 1982-08-25 | 27 |
| K822187 | Kelleher Corp. | TONSIL DISSECTORS | 1982-08-24 | 32 |
| K822203 | Kelleher Corp. | KNIFE HANDLE | 1982-08-20 | 28 |
Recalls for KTG devices
openFDA lists no recalls for product code KTG.
Frequently asked questions
What is FDA product code KTG?
KTG is the FDA product code for knife, ent. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel.
What device class is KTG?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KTG?
Across 5 cleared submissions the average was 31 days from receipt to decision (median 32).
Which companies have the most KTG clearances?
Kelleher Corp. (5).
Next steps
- Run an FDA pathway report with predicate devices for product code KTG
- Run a recall and safety report across every KTG manufacturer
- Watch product code KTG 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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