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

Instrument, Shunt System Implantation

21 CFR 882.4545 / Neurology
FDA source (opens on fda.gov)

GYK is the FDA product code for Instrument, Shunt System Implantation, a class I device type, regulated under 21 CFR 882.4545. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GYK
Device name
Instrument, Shunt System Implantation
Regulation
21 CFR 882.4545
Device class
Class I
Review panel
Neurology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
13
Ingested recalls
1

Clearances, product code GYK

By decision year
13 clearances under product code GYK with a decision year between 1977 and 1996, 1993 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GYK by decision year
YearClearances
19771
19791
19841
19852
19872
19881
19891
19933
19961

Applicants with the most clearances

Product code GYK
Applicants holding the most 510(k) clearances under product code GYK
ApplicantClearances
Holter-Hausner Intl.5
Cordis US Corp.2
American V. Mueller1
Baxter Healthcare Corporation1
Cerenovus, Inc.1
Cook Inc.1
Pudenz-Schulte Medical Research Corp.1
Radionics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order