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

Administrations Sets With Neuraxial Connectors

21 CFR 880.5440 / General Hospital
FDA source (opens on fda.gov)

PWH is the FDA product code for Administrations Sets With Neuraxial Connectors, a class II device type, regulated under 21 CFR 880.5440. FDA's definition for this code reads: "The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PWH
Device name
Administrations Sets With Neuraxial Connectors
FDA definition
The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code PWH

By decision year
4 clearances under product code PWH with a decision year between 2017 and 2023, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PWH by decision year
YearClearances
20171
20181
20211
20231

Applicants with the most clearances

Product code PWH
Applicants holding the most 510(k) clearances under product code PWH
ApplicantClearances
Abbott Medical2
Baxter Healthcare Corporation1
Care Fusion1

Companies listing this code with FDA

Companies whose registered establishments list this code