FDA product code GDN: Knife, Amputation
GDN is the FDA product code for knife, amputation. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under GDN. The average 510(k) review took 56 days (median 56).
Classification
| Field | Value |
|---|---|
| Device name | Knife, Amputation |
| 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 GDN clearance
Top GDN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Artiberia | 1 | 1985-06-20 |
Most recent GDN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851752 | Artiberia | 9-190,9-200,9-210,9-220 AMPUTATION KNIVES, VARIOUS | 1985-06-20 | 56 |
Recalls for GDN devices
openFDA lists no recalls for product code GDN.
Frequently asked questions
What is FDA product code GDN?
GDN is the FDA product code for knife, amputation. 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 GDN?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GDN?
Across 1 cleared submissions the average was 56 days from receipt to decision (median 56).
Which companies have the most GDN clearances?
Artiberia (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GDN
- Run a recall and safety report across every GDN manufacturer
- Watch product code GDN 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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