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

Dura Substitute

21 CFR 882.5910 / Neurology
FDA source (opens on fda.gov)

GXQ is the FDA product code for Dura Substitute, a class II device type, regulated under 21 CFR 882.5910. As of , FDA records hold 43 510(k) clearances under this code, the most recent dated , and 23 recalls.

Classification record

Product code
GXQ
Device name
Dura Substitute
Regulation
21 CFR 882.5910
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
43
Ingested recalls
23

Clearances, product code GXQ

By decision year
43 clearances under product code GXQ with a decision year between 1995 and 2025, 2004 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GXQ by decision year
YearClearances
19952
19961
19972
19982
19992
20002
20021
20032
20043
20052
20062
20072
20101
20122
20133
20141
20153
20163
20172
20191
20221
20231
20252

Applicants with the most clearances

Product code GXQ
Applicants holding the most 510(k) clearances under product code GXQ
ApplicantClearances
Integra LifeSciences Corporation6
Collagen Matrix, Inc5
Medtronic Neurosurgery4
Acera Surgical, Inc. C/O Linda Braddon, PhD3
Aesculap Inc3
Bio-Vascular, Inc.3
W. L. Gore & Associates, Inc.3
Cerenovus, Inc.2
Cook Biotech, Inc.2
Synthes GmbH2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 35 companies shown, in name order