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

Device, Surgical, Cryogenic

21 CFR 882.4250 / Neurology
FDA source (opens on fda.gov)

GXH is the FDA product code for Device, Surgical, Cryogenic, a class II device type, regulated under 21 CFR 882.4250. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
GXH
Device name
Device, Surgical, Cryogenic
Regulation
21 CFR 882.4250
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
23
Ingested recalls
2

Clearances, product code GXH

By decision year
23 clearances under product code GXH with a decision year between 1978 and 2025, 2018 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GXH by decision year
YearClearances
19781
19831
19861
20031
20051
20102
20121
20131
20142
20151
20171
20183
20201
20211
20221
20231
20242
20251

Applicants with the most clearances

Product code GXH
Applicants holding the most 510(k) clearances under product code GXH
ApplicantClearances
Myoscience, Inc.8
AtriCure, Inc.7
Pacira Biosciences, Inc.2
Spembly Medical, Ltd.2
Cryomedical Instruemts, Ltd.1
Cryomedical Instruments, Ltd.1
Pacira Pharmaceuticals, Inc1
CooperSurgical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code