510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K173527Substantially Equivalent

Digitex Delivery Device

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

K173527 is the FDA 510(k) clearance record for Digitex Delivery Device, a class II device, cleared for Coloplast A/S on under FDA product code PWI (Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse). FDA's definition for product code PWI reads: "Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transvaginal 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 K173527.

Clearance record

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

Clearances, product code PWI

Trailing 12 months

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

FDA records show no clearances under product code PWI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PWI, 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