FDA product code KGF: Adhesive, Tissue For Aneurysmorrhaphy
KGF is the FDA product code for adhesive, tissue for aneurysmorrhaphy. It is a Class III device, reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under KGF. The average 510(k) review took 148 days (median 148).
Classification
| Field | Value |
|---|---|
| Device name | Adhesive, Tissue For Aneurysmorrhaphy |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Compare with all 510(k) review times · Search every KGF clearance
Top KGF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Valleylab, Inc. | 1 | 1989-06-01 |
Most recent KGF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890021 | Valleylab, Inc. | STERILE POLYHESIVE PBS DRESSING | 1989-06-01 | 148 |
Recalls for KGF devices
openFDA lists no recalls for product code KGF.
Frequently asked questions
What is FDA product code KGF?
KGF is the FDA product code for adhesive, tissue for aneurysmorrhaphy. It is a Class III device, reviewed by the Neurology panel.
What device class is KGF?
Class III. Typical premarket route: PMA.
How long does a 510(k) take for product code KGF?
Across 1 cleared submissions the average was 148 days from receipt to decision (median 148).
Which companies have the most KGF clearances?
Valleylab, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KGF
- Run a recall and safety report across every KGF manufacturer
- Watch product code KGF 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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