FDA product code KGG: Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
KGG is the FDA product code for tissue adhesive for use in embolization of brain arteriovenous malformations. It is a Class III device, reviewed by the Neurology panel. Devices under KGG reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 2 recalls for KGG devices.
Classification
| Field | Value |
|---|---|
| Device name | Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for KGG devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-10-11.
Frequently asked questions
What is FDA product code KGG?
KGG is the FDA product code for tissue adhesive for use in embolization of brain arteriovenous malformations. It is a Class III device, reviewed by the Neurology panel.
What device class is KGG?
Class III. Typical premarket route: PMA.
Have KGG devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2013-10-11.
Next steps
- Run an FDA pathway report with predicate devices for product code KGG
- Run a recall and safety report across every KGG manufacturer
- Watch product code KGG 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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