510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112386Substantially Equivalent

Exair Anterior and Posterior Prolapse Repair System

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

K112386 is the FDA 510(k) clearance record for EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM, a class III device, cleared for Coloplast Corp. on under FDA product code OTP (Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed). FDA's definition for product code OTP reads: "Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed...". FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K112386.

Clearance record

Decision date
Received
(21 days to decision)
Product code
OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Regulation
21 CFR 884.5980
Device class
Class III
Review panel
Obstetrics/Gynecology
Applicant
Coloplast Corp. 1601 W. River N, Minneapolis MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OTP

Trailing 12 months

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

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