510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GETClass I

Motor, Surgical Instrument, Pneumatic Powered

21 CFR 878.4820 / General, Plastic Surgery
FDA source (opens on fda.gov)

GET is the FDA product code for Motor, Surgical Instrument, Pneumatic Powered, a class I device type, regulated under 21 CFR 878.4820. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 54 recalls.

Classification record

Product code
GET
Device name
Motor, Surgical Instrument, Pneumatic Powered
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
23
Ingested recalls
54

Clearances, product code GET

By decision year
23 clearances under product code GET with a decision year between 1979 and 1996, 1995 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code GET by decision year
YearClearances
19791
19801
19835
19842
19861
19871
19891
19901
19911
19921
19956
19962

Applicants with the most clearances

Product code GET
Applicants holding the most 510(k) clearances under product code GET
ApplicantClearances
Midas Rex Pneumatic Tools, Inc.5
Amsco Co.4
Surgical Dynamics Ltd2
United States Surgical, A Division of Tyco Healthc2
Aesculap Inc1
American Safety1
American Silk Sutures, Inc.1
Eder Instrument Co, Inc.1
Micro-Aire Surgical Instruments, Inc.1
Sen Tech Medical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 36 companies shown, in name order