FDA product code KAM: Cannula, Sinus
KAM is the FDA product code for cannula, sinus. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 19 510(k) submissions under KAM, from 6 different applicants. The average 510(k) review took 122 days (median 85). FDA has posted 2 recalls for KAM devices.
Classification
| Field | Value |
|---|---|
| Device name | Cannula, Sinus |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KAM clearance
Top KAM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Acclarent, Inc. | 8 | 2011-10-07 |
| Xomed, Inc. | 3 | 2000-02-08 |
| Atos Medical AB | 3 | 1995-02-21 |
| Micromedics, Inc. | 2 | 2005-04-27 |
| Smith & Nephew Richards, Inc. | 2 | 1995-05-11 |
1 more applicants have KAM clearances. See the full list in Caduvo.
Most recent KAM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K110687 | Acclarent, Inc. | RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) | 2011-10-07 | 210 |
| K093594 | Acclarent, Inc. | MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER | 2010-03-03 | 104 |
| K083574 | Acclarent, Inc. | RELIEVA STRATUS MICROFLOW SPACER | 2009-01-29 | 57 |
| K072891 | Acclarent, Inc. | SINUS SPACER | 2008-03-19 | 161 |
| K073041 | Acclarent, Inc. | RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER | 2008-03-11 | 134 |
Recalls for KAM devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-04-28.
Frequently asked questions
What is FDA product code KAM?
KAM is the FDA product code for cannula, sinus. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is KAM?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KAM?
Across 19 cleared submissions the average was 122 days from receipt to decision (median 85).
Which companies have the most KAM clearances?
Acclarent, Inc. (8); Xomed, Inc. (3); Atos Medical AB (3); Micromedics, Inc. (2); Smith & Nephew Richards, Inc. (2).
Have KAM devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2015-04-28.
Next steps
- Run an FDA pathway report with predicate devices for product code KAM
- Run a recall and safety report across every KAM manufacturer
- Watch product code KAM 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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