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

File, Surgical, General & Plastic Surgery

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

GEO is the FDA product code for File, Surgical, General & Plastic Surgery, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GEO
Device name
File, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4800
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
2
Ingested recalls
0

Clearances, product code GEO

By decision year
2 clearances under product code GEO with a decision year between 1983 and 1984, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GEO by decision year
YearClearances
19831
19841

Applicants with the most clearances

Product code GEO
Applicants holding the most 510(k) clearances under product code GEO
ApplicantClearances
Med-Tool, Inc.1
Unisplint Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 61 companies shown, in name order