FDA product code KBG: Trocar, Sinus
KBG is the FDA product code for trocar, sinus. It is a Class I device, regulated under 21 CFR 874.4420 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 3 510(k) submissions under KBG, from 3 different applicants. The average 510(k) review took 244 days (median 87).
Classification
| Field | Value |
|---|---|
| Device name | Trocar, Sinus |
| 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 KBG clearance
Top KBG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Clearmedical, Inc. | 1 | 2005-06-03 |
| Adven Medical | 1 | 2002-03-01 |
| Chesebrough-Pond'S U.S.A. Co. | 1 | 1985-01-15 |
Most recent KBG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K033591 | Clearmedical, Inc. | REPROCESSED TROCARS | 2005-06-03 | 568 |
| K013987 | Adven Medical | REPROCESSED DISPOSABLE TROCARS | 2002-03-01 | 87 |
| K844186 | Chesebrough-Pond'S U.S.A. Co. | CONTINENT STOMA SYSTEM & ACCESSORIES | 1985-01-15 | 78 |
Recalls for KBG devices
openFDA lists no recalls for product code KBG.
Frequently asked questions
What is FDA product code KBG?
KBG is the FDA product code for trocar, sinus. 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 KBG?
Class I, regulation 21 CFR 874.4420. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KBG?
Across 3 cleared submissions the average was 244 days from receipt to decision (median 87).
Which companies have the most KBG clearances?
Clearmedical, Inc. (1); Adven Medical (1); Chesebrough-Pond'S U.S.A. Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KBG
- Run a recall and safety report across every KBG manufacturer
- Watch product code KBG 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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