FDA product code GDR: Saw, Manual And Accessories
GDR is the FDA product code for saw, manual and accessories. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under GDR, from 2 different applicants. The average 510(k) review took 42 days (median 42). FDA has posted 1 recall for GDR devices.
Classification
| Field | Value |
|---|---|
| Device name | Saw, Manual And Accessories |
| 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 |
Top GDR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Solway, Inc. | 1 | 1987-12-30 |
| Artiberia | 1 | 1985-06-20 |
Most recent GDR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K874961 | Solway, Inc. | BONE CUTTING INSTRUMENTS & ACCESSORIES | 1987-12-30 | 28 |
| K851787 | Artiberia | 27-100 TO 29-130 VARIOUS BONE SAWS-CHARRIERE, SATT | 1985-06-20 | 56 |
Recalls for GDR devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-05-11.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code GDR?
GDR is the FDA product code for saw, manual and accessories. 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 GDR?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GDR?
Across 2 cleared submissions the average was 42 days from receipt to decision (median 42).
Which companies have the most GDR clearances?
Solway, Inc. (1); Artiberia (1).
Have GDR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-05-11.
Next steps
- Run an FDA pathway report with predicate devices for product code GDR
- Run a recall and safety report across every GDR manufacturer
- Watch product code GDR 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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