FDA product code GED: Brush, Dermabrasion, Manual
GED is the FDA product code for brush, dermabrasion, manual. 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 GED, from 2 different applicants. The average 510(k) review took 74 days (median 74).
Classification
| Field | Value |
|---|---|
| Device name | Brush, Dermabrasion, Manual |
| 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 GED clearance
Top GED applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ritmed, Inc. | 1 | 1983-05-09 |
| Bel-Med, Inc. | 1 | 1982-07-28 |
Most recent GED clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K830259 | Ritmed, Inc. | PROTET SOAP & WASH MITT | 1983-05-09 | 104 |
| K821801 | Bel-Med, Inc. | NORSEN DEBRIDER | 1982-07-28 | 43 |
Recalls for GED devices
openFDA lists no recalls for product code GED.
Frequently asked questions
What is FDA product code GED?
GED is the FDA product code for brush, dermabrasion, manual. 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 GED?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GED?
Across 2 cleared submissions the average was 74 days from receipt to decision (median 74).
Which companies have the most GED clearances?
Ritmed, Inc. (1); Bel-Med, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GED
- Run a recall and safety report across every GED manufacturer
- Watch product code GED 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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