FDA product code KAS: Knife, Nasal
KAS is the FDA product code for knife, nasal. 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 KAS. The average 510(k) review took 16 days (median 16).
Classification
| Field | Value |
|---|---|
| Device name | Knife, Nasal |
| 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 KAS clearance
Top KAS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Howmedica Corp. | 1 | 1978-11-15 |
Most recent KAS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K781837 | Howmedica Corp. | WOUND SPAN BRIDGE III | 1978-11-15 | 16 |
Recalls for KAS devices
openFDA lists no recalls for product code KAS.
Frequently asked questions
What is FDA product code KAS?
KAS is the FDA product code for knife, nasal. 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 KAS?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KAS?
Across 1 cleared submissions the average was 16 days from receipt to decision (median 16).
Which companies have the most KAS clearances?
Howmedica Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KAS
- Run a recall and safety report across every KAS manufacturer
- Watch product code KAS 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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