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

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

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

PWK is the FDA product code for Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal 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 transabdominal pelvic organ prolapse repair". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PWK
Device name
Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse
FDA definition
Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transabdominal 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
1
Ingested recalls
0

Clearances, product code PWK

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

Applicants with the most clearances

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

Companies listing this code with FDA

Companies whose registered establishments list this code