FDA product code KGD: Scissors For Cystoscope
KGD is the FDA product code for scissors for cystoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under KGD, from 2 different applicants. The average 510(k) review took 54 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | Scissors For Cystoscope |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every KGD clearance
Top KGD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arent Fox | 1 | 1994-11-17 |
| Zinnanti Surgical Instruments, Inc. | 1 | 1989-04-12 |
Most recent KGD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944054 | Arent Fox | POWDER FREE SURGEON'S GLOVE | 1994-11-17 | 90 |
| K891902 | Zinnanti Surgical Instruments, Inc. | CHISELS- FREER, LUCAS, ALEXANDER, BISHOP | 1989-04-12 | 19 |
Recalls for KGD devices
openFDA lists no recalls for product code KGD.
Frequently asked questions
What is FDA product code KGD?
KGD is the FDA product code for scissors for cystoscope. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is KGD?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code KGD?
Across 2 cleared submissions the average was 54 days from receipt to decision (median 54).
Which companies have the most KGD clearances?
Arent Fox (1); Zinnanti Surgical Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KGD
- Run a recall and safety report across every KGD manufacturer
- Watch product code KGD 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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