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

Discriminator, Two-Point

21 CFR 882.1200 / Neurology
FDA source (opens on fda.gov)

GWI is the FDA product code for Discriminator, Two-Point, a class I device type, regulated under 21 CFR 882.1200. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GWI
Device name
Discriminator, Two-Point
Regulation
21 CFR 882.1200
Device class
Class I
Review panel
Neurology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code GWI

By decision year
2 clearances under product code GWI with a decision year between 1987 and 1995, 1987 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GWI by decision year
YearClearances
19871
19951

Applicants with the most clearances

Product code GWI
Applicants holding the most 510(k) clearances under product code GWI
ApplicantClearances
Jcm Management & Planning Co.1
Mizuho Orthopedic Systems Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order