510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PWIClass II

Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse

21 CFR 884.4910 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

PWI is the FDA product code for Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse, a class II device type, regulated under 21 CFR 884.4910. FDA's definition for this code reads: "Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transvaginal pelvic organ prolapse repair". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 13 recalls.

Classification record

Product code
PWI
Device name
Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
FDA definition
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transvaginal pelvic organ prolapse repair
Regulation
21 CFR 884.4910
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
2
Ingested recalls
13

Clearances, product code PWI

By decision year
2 clearances under product code PWI with a decision year between 2017 and 2018, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PWI by decision year
YearClearances
20171
20181

Applicants with the most clearances

Product code PWI
Applicants holding the most 510(k) clearances under product code PWI
ApplicantClearances
Boston Scientific Corporation1
MEDLINE INDUSTRIES, LP - Northfield1

Companies listing this code with FDA

Companies whose registered establishments list this code