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

Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery

21 CFR 884.5210 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

PNU is the FDA product code for Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery, a class II device type, regulated under 21 CFR 884.5210. FDA's definition for this code reads: "Designed to provide counter-pressure to the perianal region during vaginal childbirth to help reduce the likelihood of Cesarean delivery". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PNU
Device name
Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery
FDA definition
Designed to provide counter-pressure to the perianal region during vaginal childbirth to help reduce the likelihood of Cesarean delivery
Regulation
21 CFR 884.5210
Device class
Class II
Review panel
Obstetrics/Gynecology
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 PNU

By decision year
1 clearance under product code PNU with a decision year between 2016 and 2016, 2016 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PNU by decision year
YearClearances
20161

Applicants with the most clearances

Product code PNU
Applicants holding the most 510(k) clearances under product code PNU
ApplicantClearances
Stetrix Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code