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

Needle, Suturing, Reusable

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

GDL is the FDA product code for Needle, Suturing, Reusable, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GDL
Device name
Needle, Suturing, Reusable
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
5
Ingested recalls
0

Clearances, product code GDL

By decision year
5 clearances under product code GDL with a decision year between 1981 and 1988, 1985 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GDL by decision year
YearClearances
19811
19821
19852
19881

Applicants with the most clearances

Product code GDL
Applicants holding the most 510(k) clearances under product code GDL
ApplicantClearances
Artiberia2
China National Medicines C/O Havel'S1
Ortho Pared Instruments, Inc.1
S. Jackson, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 81 companies shown, in name order