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

Gauze/Sponge, Internal, X-Ray Detectable

21 CFR 878.4450 / General, Plastic Surgery
FDA source (opens on fda.gov)

GDY is the FDA product code for Gauze/Sponge, Internal, X-Ray Detectable, a class I device type, regulated under 21 CFR 878.4450. As of , FDA records hold 111 510(k) clearances under this code, the most recent dated , and 66 recalls.

Classification record

Product code
GDY
Device name
Gauze/Sponge, Internal, X-Ray Detectable
Regulation
21 CFR 878.4450
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
111
Ingested recalls
66

Clearances, product code GDY

By decision year
111 clearances under product code GDY with a decision year between 1977 and 1997, 1994 the highest year at 27.
Show the numbers
510(k) clearances under FDA product code GDY by decision year
YearClearances
19772
19783
19794
19807
198113
19823
19838
19843
19852
19862
19873
19884
19892
19901
19914
19925
19931
199427
199514
19962
19971

Applicants with the most clearances

Product code GDY
Applicants holding the most 510(k) clearances under product code GDY
ApplicantClearances
Lorrex Health Products9
Medical Perspectives Corp.7
Thantex Specialties, Inc.7
Ultracell Medical Technologies, Inc.7
McNeil Healthcare LLC5
Medspec Corp.4
American Silk Sutures, Inc.3
Bioseal3
Ormed Mfg., Inc.3
Winn Hirsch & Assoc.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 190 companies shown, in name order