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

Guide, Needle, Surgical

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

GDF is the FDA product code for Guide, Needle, Surgical, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and 20 recalls.

Classification record

Product code
GDF
Device name
Guide, Needle, Surgical
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
28
Ingested recalls
20

Clearances, product code GDF

By decision year
28 clearances under product code GDF with a decision year between 1982 and 2003, 1992 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code GDF by decision year
YearClearances
19823
19831
19851
19863
19881
19893
19902
19924
19933
19944
19952
20031

Applicants with the most clearances

Product code GDF
Applicants holding the most 510(k) clearances under product code GDF
ApplicantClearances
Conphar, Inc.3
Kinetic Medical Products3
Bip USA, Inc.2
E-Z-EM, Inc2
General Electric Co.2
Guardian Angel Products, Inc.2
Angiodynamics, Div. E-Z-Em, Inc.1
Bauer Medical, Inc.1
Buckman Co., Inc.1
Core Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 225 companies shown, in name order