510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121641Substantially Equivalent

Miniarc Pro Single-Incision Sling System

American Medical Systems, Inc., Minnetonka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121641 is the FDA 510(k) clearance record for MINIARC PRO SINGLE-INCISION SLING SYSTEM, a class II device, cleared for American Medical Systems on under FDA product code PAH (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling). FDA's definition for product code PAH reads: "Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility". FDA records list 82 510(k) clearances for American Medical Systems, from to . As of , FDA records show one recall naming K121641.

Clearance record

Decision date
Received
(95 days to decision)
Product code
PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
American Medical Systems 10700 Bren Rd. W., Minnetonka MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PAH

Trailing 12 months

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

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