FDA product code KAB: Trocar, Laryngeal
KAB is the FDA product code for trocar, laryngeal. 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 KAB. The average 510(k) review took 51 days (median 51).
Classification
| Field | Value |
|---|---|
| Device name | Trocar, Laryngeal |
| 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 KAB clearance
Top KAB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Device Services | 1 | 2002-10-09 |
Most recent KAB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022743 | Medical Device Services | REPROCESSED DISPOSABLE TROCARS | 2002-10-09 | 51 |
Recalls for KAB devices
openFDA lists no recalls for product code KAB.
Frequently asked questions
What is FDA product code KAB?
KAB is the FDA product code for trocar, laryngeal. 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 KAB?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KAB?
Across 1 cleared submissions the average was 51 days from receipt to decision (median 51).
Which companies have the most KAB clearances?
Medical Device Services (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KAB
- Run a recall and safety report across every KAB manufacturer
- Watch product code KAB 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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