FDA product code KTE: Trocar, Ent
KTE is the FDA product code for trocar, 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 1 510(k) submission under KTE. The average 510(k) review took 24 days (median 24).
Classification
| Field | Value |
|---|---|
| Device name | Trocar, 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 |
Top KTE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 1 | 1982-08-16 |
Most recent KTE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822168 | Kelleher Corp. | ANTRUM TROCARS | 1982-08-16 | 24 |
Recalls for KTE devices
openFDA lists no recalls for product code KTE.
Frequently asked questions
What is FDA product code KTE?
KTE is the FDA product code for trocar, 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 KTE?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KTE?
Across 1 cleared submissions the average was 24 days from receipt to decision (median 24).
Which companies have the most KTE clearances?
Kelleher Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KTE
- Run a recall and safety report across every KTE manufacturer
- Watch product code KTE 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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