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

Dissector, Surgical, General & Plastic Surgery

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

GDI is the FDA product code for Dissector, Surgical, General & Plastic Surgery, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
GDI
Device name
Dissector, 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
7
Ingested recalls
6

Clearances, product code GDI

By decision year
7 clearances under product code GDI with a decision year between 1979 and 1989, 1979 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GDI by decision year
YearClearances
19792
19811
19821
19831
19851
19891

Applicants with the most clearances

Product code GDI
Applicants holding the most 510(k) clearances under product code GDI
ApplicantClearances
Beecher Medical Diagnostic Instrumentation1
Carwild Corp.1
Edward Weck, Inc.1
Galenica Enterprises, Inc.1
Kelleher Corp.1
Ormed Mfg., Inc.1
V. Mueller O.V. Baxter Healthcare Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 255 companies shown, in name order