FDA product code KBC: Saw, Nasal
KBC is the FDA product code for saw, 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 4 510(k) submissions under KBC, from 3 different applicants. The average 510(k) review took 44 days (median 47).
Classification
| Field | Value |
|---|---|
| Device name | Saw, 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 KBC clearance
Top KBC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| United States Surgical, A Division of Tyco Healthc | 2 | 1981-03-20 |
| Sierra Laboratories, Inc. | 1 | 1981-07-27 |
| Edward Weck, Inc. | 1 | 1978-02-02 |
Most recent KBC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K811887 | Sierra Laboratories, Inc. | SKIN STAPLE EXTRACTOR | 1981-07-27 | 26 |
| K810187 | United States Surgical, A Division of Tyco Healthc | AUTO SUTURE PSS SKIN STAPLING INSTRUMENT | 1981-03-20 | 57 |
| K810188 | United States Surgical, A Division of Tyco Healthc | AUTO SUTURE GAS POWERED DISP. LDS STAPL | 1981-03-20 | 57 |
| K772379 | Edward Weck, Inc. | JOSEPH SAW | 1978-02-02 | 37 |
Recalls for KBC devices
openFDA lists no recalls for product code KBC.
Frequently asked questions
What is FDA product code KBC?
KBC is the FDA product code for saw, 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 KBC?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KBC?
Across 4 cleared submissions the average was 44 days from receipt to decision (median 47).
Which companies have the most KBC clearances?
United States Surgical, A Division of Tyco Healthc (2); Sierra Laboratories, Inc. (1); Edward Weck, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KBC
- Run a recall and safety report across every KBC manufacturer
- Watch product code KBC 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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