510(k) · Cleared

Cleared

Laparotomy Bladder Neck Suspension Kit

K971801510(k) TraditionalCleared Jul 22, 199768-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

Louisville Laboratories, Inc. · EZL Catheter, Retention Type, Balloon

Cleared on Jul 22, 1997 as substantially equivalent to K963076 (Louisville Laboratories, Inc., 1997) and 1 other predicate after a 68-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided: Jul 22, 1997
Review: 68 days
Class: Class II
Product code: EZL
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K932553 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK932553 Disposable Suture Placement SystemLaurus Medical Corp. · 1994 · Recalled
This deviceK971801 Laparotomy Bladder Neck Suspension KitLouisville Laboratories, Inc. · 1997
Descendant · cites it directly · 0 of its ownK982626 Urethropexy Suture Placement Kit Model Numbers UM-300, MW-100…Medworks Corp. · 1998

Most influential descendants

Showing 1 of 1 · See all

K982626Urethropexy Suture Placement Kit Model Numbers UM-300, MW-100, Mini-Laparotomy MMK Kit…Medworks Corp. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K932553	Disposable Suture Placement System	Laurus Medical Corp.	1994	2
0 (this device)	K971801	Laparotomy Bladder Neck Suspension Kit	Louisville Laboratories, Inc.	1997	—
+1	K982626	Urethropexy Suture Placement Kit Model Numbers UM-300, MW-100, Mini-Laparotomy…	Medworks Corp.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K971801, 1994–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K260756 TraumaGuard Intra-Abdominal Pressure-Sensing…score 13.2 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K963076	Laparoscopic Bone Anchored Urethropexy Instrument Tray Summary page 1 …k Suspension Kit is substantially equivalent to several devices on the market such as the Louisville laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray (K963076), the Laurus Medical Suturing System (K932553) and several surgical techniques that have been performed for over forty years. Lo…	Louisville Laboratories, Inc.	1997	—
*	K932553	Disposable Suture Placement System Summary page 1 …o several devices on the market such as the Louisville laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray (K963076), the Laurus Medical Suturing System (K932553) and several surgical techniques that have been performed for over forty years. Louisville Laboratories, Inc. _ Bladder Neck Sus…	Laurus Medical Corp.	1994	2

Also cleared against K963076: 5 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K982626	Urethropexy Suture Placement Kit Model Numbers UM-300, MW-100, Mini-Laparotomy MMK Kit…	Medworks Corp.	1998	0

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K982626 (Medworks Corp., 1998) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K963076.

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

2007high 9 (2018) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EZL

123in 2024

2007high 282 (2023) · low 114 (2009)2026

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

Recalls per year · EZL

2in 2024

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	7	186	0	8
2008	2	—	0	6
2009	4	114	0	6
2010	1	—	0	27
2011	2	—	0	79
2012	0	—	0	65
2013	3	151	0	99
2014	2	—	0	229
2015	3	132	0	303
2016	1	—	0	326
2017	2	—	0	571
2018	9	177	0	677
2019	3	266	1	671
2020	4	137	0	712
2021	2	—	0	702
2022	2	—	0	884
2023	3	282	2 (2)	772
2024	5	123	2	1,029
2025	1	—	0	1,381
2026	4	170	2	—

What is it indicated for?

The Louisville Laboratories, Inc. Laparotomy Bladder Neck Suspension Kit is indicated for urethropexy procedures for bladder neck suspension to correct female stress 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.

https://510kreport.com/device/K971801 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971801: Laparotomy Bladder Neck Suspension Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971801

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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