FDA product code NGR: Tester, Stiffness, Cartilage, Arthroscopic
NGR is the FDA product code for tester, stiffness, cartilage, arthroscopic. It is a Class II device, regulated under 21 CFR 888.1100 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under NGR, from 2 different applicants. The average 510(k) review took 184 days (median 184).
Classification
| Field | Value |
|---|---|
| Device name | Tester, Stiffness, Cartilage, Arthroscopic |
| Device class | Class II |
| Regulation | 21 CFR 888.1100 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NGR clearance
Top NGR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Osteobiologics, Inc. | 1 | 2002-01-11 |
| Artscan Medical Innovations | 1 | 2001-09-11 |
Most recent NGR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K013429 | Osteobiologics, Inc. | ACTAEON PROBE | 2002-01-11 | 87 |
| K010303 | Artscan Medical Innovations | ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE | 2001-09-11 | 280 |
Recalls for NGR devices
openFDA lists no recalls for product code NGR.
Frequently asked questions
What is FDA product code NGR?
NGR is the FDA product code for tester, stiffness, cartilage, arthroscopic. It is a Class II device, regulated under 21 CFR 888.1100 and reviewed by the Orthopedic panel.
What device class is NGR?
Class II, regulation 21 CFR 888.1100. Typical premarket route: 510(k).
How long does a 510(k) take for product code NGR?
Across 2 cleared submissions the average was 184 days from receipt to decision (median 184).
Which companies have the most NGR clearances?
Osteobiologics, Inc. (1); Artscan Medical Innovations (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NGR
- Run a recall and safety report across every NGR manufacturer
- Watch product code NGR 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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