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

Optical Neurosurgical Nerve Locator

21 CFR 874.1820 / Ear, Nose, Throat
FDA source (opens on fda.gov)

QWP is the FDA product code for Optical Neurosurgical Nerve Locator, a class II device type, regulated under 21 CFR 874.1820. FDA's definition for this code reads: "To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QWP
Device name
Optical Neurosurgical Nerve Locator
FDA definition
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
Regulation
21 CFR 874.1820
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QWP

By decision year
1 clearance under product code QWP with a decision year between 2023 and 2023, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QWP by decision year
YearClearances
20231

Applicants with the most clearances

Product code QWP
Applicants holding the most 510(k) clearances under product code QWP
ApplicantClearances
Waypoint Orthopedics1

Companies listing this code with FDA

Companies whose registered establishments list this code