FDA product code NBG: Marker, Colon
NBG is the FDA product code for marker, colon. 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 NBG, from 2 different applicants. The average 510(k) review took 118 days (median 118).
Classification
| Field | Value |
|---|---|
| Device name | Marker, Colon |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NBG clearance
Top NBG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pmt Corp. | 1 | 2005-03-16 |
| Chek-Med Systems | 1 | 2000-02-18 |
Most recent NBG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K042901 | Pmt Corp. | ENDOMARK STERILE INDIA INK | 2005-03-16 | 147 |
| K993951 | Chek-Med Systems | SPOT ENDOSCOPIC MARKER | 2000-02-18 | 88 |
Recalls for NBG devices
openFDA lists no recalls for product code NBG.
Frequently asked questions
What is FDA product code NBG?
NBG is the FDA product code for marker, colon. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is NBG?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NBG?
Across 2 cleared submissions the average was 118 days from receipt to decision (median 118).
Which companies have the most NBG clearances?
Pmt Corp. (1); Chek-Med Systems (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NBG
- Run a recall and safety report across every NBG manufacturer
- Watch product code NBG 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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