FDA product code GEY: Motor, Surgical Instrument, Ac-Powered
GEY is the FDA product code for motor, surgical instrument, ac-powered. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel. FDA has cleared 41 510(k) submissions under GEY, from 28 different applicants. The average 510(k) review took 86 days (median 78). FDA has posted 27 recalls for GEY devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Motor, Surgical Instrument, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 878.4820 |
| 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 GEY clearance
Top GEY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biomedical Ent., Inc. | 3 | 1997-07-29 |
| The Anspach Effort, Inc. | 3 | 1997-05-05 |
| Micro Surgical Instruments Corp. | 3 | 1991-11-01 |
| American Surgical Laser, Inc. | 3 | 1984-12-07 |
| Linvatec Corp. | 2 | 2005-05-17 |
23 more applicants have GEY clearances. See the full list in Caduvo.
Most recent GEY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050519 | Linvatec Corp. | ADVANCED TURBO DRIVE SYSTEM | 2005-05-17 | 77 |
| K020621 | Arthrocare Corp. | ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS | 2002-03-28 | 30 |
| K012738 | Depuyacromed | SYMPHONY GRAFT DELIVERY SYSTEM (GDS) | 2001-11-14 | 90 |
| K972308 | Mednext, Inc. | MEDNEXT 1000 DRILL | 1997-08-20 | 61 |
| K971941 | Boyd Industries, Inc. | AQUA SPRAY | 1997-08-14 | 79 |
Recalls for GEY devices
27 product recalls in 13 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-02-15.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code GEY?
GEY is the FDA product code for motor, surgical instrument, ac-powered. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel.
What device class is GEY?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GEY?
Across 41 cleared submissions the average was 86 days from receipt to decision (median 78).
Which companies have the most GEY clearances?
Biomedical Ent., Inc. (3); The Anspach Effort, Inc. (3); Micro Surgical Instruments Corp. (3); American Surgical Laser, Inc. (3); Linvatec Corp. (2).
Have GEY devices been recalled?
Yes: 27 product recalls across 13 recall events; the most recent began 2023-02-15.
Next steps
- Run an FDA pathway report with predicate devices for product code GEY
- Run a recall and safety report across every GEY manufacturer
- Watch product code GEY 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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