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

Scalpel, One-Piece

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

GDX is the FDA product code for Scalpel, One-Piece, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
GDX
Device name
Scalpel, One-Piece
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
26
Ingested recalls
6

Clearances, product code GDX

By decision year
26 clearances under product code GDX with a decision year between 1978 and 1992, 1982 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code GDX by decision year
YearClearances
19781
19791
19801
19811
19825
19831
19842
19853
19862
19871
19881
19892
19901
19912
19922

Applicants with the most clearances

Product code GDX
Applicants holding the most 510(k) clearances under product code GDX
ApplicantClearances
Abco Dealers, Inc.1
Applied Medical Technologies1
Artiberia1
Ascep, Inc.1
Buckman Co., Inc.1
CooperVision, Inc.1
Depuy, Inc.1
Diverse Technologies, Inc.1
Icn Pharmaceuticals, Inc.1
Imm Enterprises, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 150 companies shown, in name order