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

Neurological Stereotaxic Instrument

21 CFR 882.4560 / Neurology
FDA source (opens on fda.gov)

HAW is the FDA product code for Neurological Stereotaxic Instrument, a class II device type, regulated under 21 CFR 882.4560. As of , FDA records hold 424 510(k) clearances under this code, the most recent dated , and 197 recalls.

Classification record

Product code
HAW
Device name
Neurological Stereotaxic Instrument
Regulation
21 CFR 882.4560
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
425
Ingested recalls
197

Clearances, product code HAW

By decision year
425 clearances under product code HAW with a decision year between 1979 and 2026, 1999 the highest year at 28.
Show the numbers
510(k) clearances under FDA product code HAW by decision year
YearClearances
19791
19812
19835
19854
19863
19871
19885
19892
19902
19911
19923
19931
19941
19955
199612
199713
199820
199928
200017
200127
200223
200321
200420
200528
200622
200715
200812
20098
20106
20114
20128
20133
20145
201510
20169
20177
20186
201910
20205
20219
20227
202314
20247
20259
20264

Applicants with the most clearances

Product code HAW
Applicants holding the most 510(k) clearances under product code HAW
ApplicantClearances
Brainlab, Inc.59
Medtronic Navigation, Inc30
Elekta Instrument AB16
Image-Guided Neurologics, Inc.15
Surgical Navigation Technologies, Inc.15
Stryker Corp.14
Orthosoft, Inc.12
Radionics, Inc.11
ClearPoint Neuro Inc.10
Philips North America LLC10

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 210 companies shown, in name order