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

Endoscope, Neurological

21 CFR 882.1480 / Neurology
FDA source (opens on fda.gov)

GWG is the FDA product code for Endoscope, Neurological, a class II device type, regulated under 21 CFR 882.1480. FDA's definition for this code reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf)". As of , FDA records hold 93 510(k) clearances under this code, the most recent dated , and 22 recalls.

Classification record

Product code
GWG
Device name
Endoscope, Neurological
FDA definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Regulation
21 CFR 882.1480
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
No
Ingested clearances
93
Ingested recalls
22

Clearances, product code GWG

By decision year
93 clearances under product code GWG with a decision year between 1992 and 2026, 1995 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code GWG by decision year
YearClearances
19921
19935
19946
199510
19969
19973
19984
19995
20006
20012
20024
20031
20042
20051
20061
20082
20131
20142
20162
20174
20184
20193
20202
20213
20235
20241
20252
20262

Applicants with the most clearances

Product code GWG
Applicants holding the most 510(k) clearances under product code GWG
ApplicantClearances
Neuro Navigational Corp.15
Karl Storz Endoscopy-America, Inc.12
Aesculap Inc7
Clarus Medical Systems, Inc.7
Medtronic PS Medical4
Penumbra Inc.4
Rebound Therapeutics, Corporation4
Carl Zeiss Meditec Inc3
Clearmind Biomedical3
Cerenovus, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 54 companies shown, in name order