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Monarc Sling System

by American Medical Systems, Inc.

510(k) K023516

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK023516 Date19 Nov 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1019-04 FDA Unclassified (pre-2012) initiated 28 Jul 2003 on shared 510(k) K023516

    Insertion needles from the former version of the product were packaged with the new sling with dilator that is different than the old version and not compatible with the old needles.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OTN
Device class
Class II
Regulation
21 CFR Part 878.3300
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Monarc Sling System is a sterile, single-use surgical kit for treating female stress urinary incontinence. It is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The device is supplied as a surgical kit and is indicated for use in female patients. It has received FDA 510(k) clearance under product code OTN and regulation number 878.3300, with clearance date of November 19, 2002. The device is classified as a Class II medical device.

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