FDA product code GET: Motor, Surgical Instrument, Pneumatic Powered
GET is the FDA product code for motor, surgical instrument, pneumatic 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 23 510(k) submissions under GET, from 14 different applicants. The average 510(k) review took 85 days (median 50). FDA has posted 54 recalls for GET devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Motor, Surgical Instrument, Pneumatic 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 GET clearance
Top GET applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Midas Rex Pneumatic Tools, Inc. | 5 | 1995-10-18 |
| Amsco Co. | 4 | 1983-10-31 |
| Surgical Dynamics, Inc. | 2 | 1995-10-30 |
| United States Surgical, A Division of Tyco Healthc | 2 | 1992-06-11 |
| Aesculap, Inc. | 1 | 1996-03-07 |
9 more applicants have GET clearances. See the full list in Caduvo.
Most recent GET clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K960473 | Aesculap, Inc. | AESCULAP POWER SYSTEM HANDPIECE | 1996-03-07 | 35 |
| K955174 | Sodem Diffusion SA | SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY | 1996-01-22 | 70 |
| K942987 | Surgical Dynamics, Inc. | NUCLEOTOME L KIT | 1995-10-30 | 497 |
| K954076 | Midas Rex Pneumatic Tools, Inc. | MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS | 1995-10-18 | 49 |
| K953433 | Midas Rex Pneumatic Tools, Inc. | MIDAS REX TELESCOPING SYSTEM | 1995-09-15 | 56 |
Recalls for GET devices
54 product recalls in 7 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-02-14.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code GET?
GET is the FDA product code for motor, surgical instrument, pneumatic 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 GET?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GET?
Across 23 cleared submissions the average was 85 days from receipt to decision (median 50).
Which companies have the most GET clearances?
Midas Rex Pneumatic Tools, Inc. (5); Amsco Co. (4); Surgical Dynamics, Inc. (2); United States Surgical, A Division of Tyco Healthc (2); Aesculap, Inc. (1).
Have GET devices been recalled?
Yes: 54 product recalls across 7 recall events; the most recent began 2023-02-14.
Next steps
- Run an FDA pathway report with predicate devices for product code GET
- Run a recall and safety report across every GET manufacturer
- Watch product code GET 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times