510(k) Report

510(k) · Cleared

Cleared

Urethropexy Suture Placement Kit Model Numbers UM-300, MW-100, Mini-Laparotomy MMK Kit Model UM-250, Laparoscopic BURCH0

K982626510(k) SpecialCleared Aug 20, 199823-day reviewClass II21 CFR 876.5130

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medworks Corp. · EZL Catheter, Retention Type, Balloon

Cleared on Aug 20, 1998 as substantially equivalent to K971791 (Louisville Laboratories, Inc., 1997) and 5 other predicates after a 23-day review. Its family tree reaches back 2 generations to 1994.

Decided
Aug 20, 1998
Review
23 days
Class
Class II
Product code
EZL
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K932553 (1994). 10 ancestors in all, the oldest K931181 (1993). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 5 other ancestors1994: 1 other ancestor1993: 2 other ancestorsK932553 · Disposable Suture Placement System · Laurus Medical Corp. · 1994 · recalledK971797 · Laparoscopic Bladder Neck Suspension Kit · Louisville Laboratories, Inc. · 1997199019921994199619982000
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 3 other ancestors K971797 · Laparoscopic Bladder Neck Suspension Kit · Louisville Laboratories, Inc. · 1997K932553 · Disposable Suture Placement System · Laurus Medical Corp. · 1994 · recalled0
  1. Root · 2 generations backK932553 Disposable Suture Placement SystemLaurus Medical Corp. · 1994 · Recalled
  2. 1 generation backK971797 Laparoscopic Bladder Neck Suspension KitLouisville Laboratories, Inc. · 1997
  3. This deviceK982626 Urethropexy Suture Placement Kit Model Numbers UM-300, MW-100…Medworks Corp. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K932553Disposable Suture Placement SystemLaurus Medical Corp.19942
−1K971797Laparoscopic Bladder Neck Suspension KitLouisville Laboratories, Inc.1997—
0 (this device)K982626Urethropexy Suture Placement Kit Model Numbers UM-300, MW-100, Mini-Laparotomy…Medworks Corp.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199320
199410
199750
FIG. 1 — Lineage of K982626, 1994–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EZL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new EZL device

  1. #1 K260756 TraumaGuard Intra-Abdominal Pressure-Sensing…score 13.2 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K971791Vaginal Suturing Kit for Laparotomy Bladder Neck Suspension
Summary page 1
…inence surgical devices Classification: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class 11. Predicate Devices: K971791 - Urethropexy Suture Placement Kit K971796 - Mini-Laparotomy MMK Kit K971797 - Laparoscopic Burch Set K963076 - Laparoscopic MMK…
Louisville Laboratories, Inc.1997—
*K971796Laparotomy Bladder Neck Suspension Kit with Bone Anchors
Summary page 1
…cording to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class 11. Predicate Devices: K971791 - Urethropexy Suture Placement Kit K971796 - Mini-Laparotomy MMK Kit K971797 - Laparoscopic Burch Set K963076 - Laparoscopic MMK Kit K971801 - Mini-Laparotomy Burch Set K97…
Louisville Laboratories, Inc.1997—
*K971797Laparoscopic Bladder Neck Suspension Kit
Summary page 1
…ral Food, Drug, and Cosmetic Act, the device classification is Class 11. Predicate Devices: K971791 - Urethropexy Suture Placement Kit K971796 - Mini-Laparotomy MMK Kit K971797 - Laparoscopic Burch Set K963076 - Laparoscopic MMK Kit K971801 - Mini-Laparotomy Burch Set K971802 - Urethropexy Suture Placemen…
Louisville Laboratories, Inc.1997—
*K963076Laparoscopic Bone Anchored Urethropexy Instrument Tray
Summary page 1
…the device classification is Class 11. Predicate Devices: K971791 - Urethropexy Suture Placement Kit K971796 - Mini-Laparotomy MMK Kit K971797 - Laparoscopic Burch Set K963076 - Laparoscopic MMK Kit K971801 - Mini-Laparotomy Burch Set K971802 - Urethropexy Suture Placement Set Manufactured by: MedWorks…
Louisville Laboratories, Inc.1997—
*K971801Laparotomy Bladder Neck Suspension Kit
Summary page 1
…lass 11. Predicate Devices: K971791 - Urethropexy Suture Placement Kit K971796 - Mini-Laparotomy MMK Kit K971797 - Laparoscopic Burch Set K963076 - Laparoscopic MMK Kit K971801 - Mini-Laparotomy Burch Set K971802 - Urethropexy Suture Placement Set Manufactured by: MedWorks Corp. 2400 Crittenden Drive Lou…
Louisville Laboratories, Inc.1997—
*K971802Vaginal Suturing Kit for Bladder Neck Suspension
Summary page 1
…- Urethropexy Suture Placement Kit K971796 - Mini-Laparotomy MMK Kit K971797 - Laparoscopic Burch Set K963076 - Laparoscopic MMK Kit K971801 - Mini-Laparotomy Burch Set K971802 - Urethropexy Suture Placement Set Manufactured by: MedWorks Corp. 2400 Crittenden Drive Louisville, KY 40217 Product Descripti…
Louisville Laboratories, Inc.1997—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
  • 2 of the 10 ancestors have a recall of any class.

How does its category compare?

All EZL devices

EZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EZL

1in 2025

2007: 72008: 22009: 42010: 12011: 22013: 32014: 22015: 32016: 12017: 22018: 92019: 32020: 42021: 22022: 22023: 32024: 52025: 12026 (partial year): 4
2007high 9 (2018) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EZL

123in 2024

2007: 186 days median2009: 114 days median2013: 151 days median2015: 132 days median2018: 177 days median2019: 266 days median2020: 137 days median2023: 282 days median2024: 123 days median2026 (partial year): 170 days median
2007high 282 (2023) · low 114 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EZL

2in 2024

2019: 12023: 2, 2 Class I2024: 22026 (partial year): 2
2007high 2 (2023) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · EZL

1,381in 2025

2007: 82008: 62009: 62010: 272011: 792012: 652013: 992014: 2292015: 3032016: 3262017: 5712018: 6772019: 6712020: 7122021: 7022022: 8842023: 7722024: 1,0292025: 1,381
2007high 1,381 (2025) · low 6 (2008)2025

MAUDE reports naming product code EZL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007718608
20082—06
2009411406
20101—027
20112—079
20120—065
20133151099
20142—0229
201531320303
20161—0326
20172—0571
201891770677
201932661671
202041370712
20212—0702
20222—0884
202332822 (2)772
2024512321,029
20251—01,381
202641702—

What is it indicated for?

MedWorks Urinary Incontinence Surgical Devices are indicated for use in urethropexy surgical procedures for bladder neck suspension to correct female stress urinary incontinence due to urethral hypermobility.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Medworks Corp.

3 FDA decisions under this applicant name. See the company

  • K982630Medworks Visualization Insemination CatheterMedworks Corp. · 1999
  • K982628Medworks Insemination CatheterMedworks Corp. · 1998

Recent decisions in EZL

The EZL category page

  • K261141OpenFlo Urinary CatheterUrolution Medical, Inc. · 2026
  • K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies, · 2026
  • K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd. · 2026
  • K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd. · 2026
  • K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd. · 2025

https://510kreport.com/device/K982626 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982626: Urethropexy Suture Placement Kit Model Numbers UM-300, MW-100, Mini-Laparotomy MMK Kit Model UM-250, Laparoscopic BURCH0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982626

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026