510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K173501Substantially Equivalent

Meridian Vaginal Positioning System (VPS)

MEDLINE INDUSTRIES, LP - Northfield, Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173501 is the FDA 510(k) clearance record for Meridian Vaginal Positioning System (VPS), a class II device, cleared for Coloplast on under FDA product code PWK (Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse). FDA's definition for product code PWK reads: "Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transabdominal pelvic organ prolapse repair". FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K173501.

Clearance record

Decision date
Received
(88 days to decision)
Product code
PWK Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse
Regulation
21 CFR 884.4910
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Coloplast 1601 W. River Rd. N., Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PWK

Trailing 12 months

FDA records hold no clearances under product code PWK in the trailing twelve months.

FDA records show no clearances under product code PWK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PWK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260