510(k) Report

510(k) · Cleared

Cleared

Laparotomy Bladder Neck Suspension Kit with Bone Anchors

K971796510(k) TraditionalCleared Aug 12, 199789-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 Aug 12, 1997 as substantially equivalent to K963076 (Louisville Laboratories, Inc., 1997) and 3 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided
Aug 12, 1997
Review
89 days
Class
Class II
Product code
EZL
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K931181 (1993). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestor1998: 1 descendant clearedK931181 · Vesitec Suture Passer · Vesitec Medical, Inc. · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant K931181 · Vesitec Suture Passer · Vesitec Medical, Inc. · 19930
  1. Root · 1 generation backK931181 Vesitec Suture PasserVesitec Medical, Inc. · 1993
  2. This deviceK971796 Laparotomy Bladder Neck Suspension Kit with Bone AnchorsLouisville Laboratories, Inc. · 1997
  3. 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

GenerationNumberDeviceApplicantDecidedRecalls
−1K931181Vesitec Suture PasserVesitec Medical, Inc.1993—
0 (this device)K971796Laparotomy Bladder Neck Suspension Kit with Bone AnchorsLouisville Laboratories, Inc.1997—
+1K982626Urethropexy 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
199310
199410
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K971796, 1993–1998Source: 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
Get a 510(k) Report

What was it cleared against? (4)

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
*K963076Laparoscopic Bone Anchored Urethropexy Instrument Tray
Summary page 2
…e Anchored Urethropexy Instrument Tray Louisville Laboratories, Inc. 5/14/97 Page D-1 Laparotomy Bladder Neck Suspension Kit With Bone Anchors - 510(k) (K963076), the Microvasive Percutaneous Bladder Neck Suspension Kit, (K931181, K931182, K932925) and several surgical techniques that have…
Louisville Laboratories, Inc.1997—
*K931181Vesitec Suture Passer
Summary page 2
…5/14/97 Page D-1 Laparotomy Bladder Neck Suspension Kit With Bone Anchors - 510(k) (K963076), the Microvasive Percutaneous Bladder Neck Suspension Kit, (K931181, K931182, K932925) and several surgical techniques that have been performed for over forty years. 4. Device description The Lap…
Vesitec Medical, Inc.1993—
*K931182Vesitec Drill Guide
Summary page 2
…Page D-1 Laparotomy Bladder Neck Suspension Kit With Bone Anchors - 510(k) (K963076), the Microvasive Percutaneous Bladder Neck Suspension Kit, (K931181, K931182, K932925) and several surgical techniques that have been performed for over forty years. 4. Device description The Laparotomy B…
Vesitec Medical, Inc.1993—
*K932925Bone Anchor for Soft Tissue Attachment
Summary page 2
…Laparotomy Bladder Neck Suspension Kit With Bone Anchors - 510(k) (K963076), the Microvasive Percutaneous Bladder Neck Suspension Kit, (K931181, K931182, K932925) and several surgical techniques that have been performed for over forty years. 4. Device description The Laparotomy Bladder Ne…
Vesitec Medical, Inc.19942

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.

NumberDeviceApplicantDecidedDescendants
K982626Urethropexy Suture Placement Kit Model Numbers UM-300, MW-100, Mini-Laparotomy MMK Kit…Medworks Corp.19980

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 4 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

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?

The Louisville Laboratories, Inc. Laparotomy Bladder Neck Suspension Kit With Bone Anchors 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.

Also cleared against K963076

5 other devices cite the same predicate.

  • K982626Urethropexy Suture Placement Kit Model Numbers UM-300, MW-100, Mini-Laparotomy MMK Kit Model UM-250…Medworks Corp. · 1998
  • K971802Vaginal Suturing Kit for Bladder Neck SuspensionLouisville Laboratories, Inc. · 1997
  • K971791Vaginal Suturing Kit for Laparotomy Bladder Neck SuspensionLouisville Laboratories, Inc. · 1997
  • K971797Laparoscopic Bladder Neck Suspension KitLouisville Laboratories, Inc. · 1997
  • K971801Laparotomy Bladder Neck Suspension KitLouisville Laboratories, Inc. · 1997

More from Louisville Laboratories, Inc.

12 FDA decisions under this applicant name. See the company

  • K980123Carter-Thomason Needle-Point Suture Passer Instrument SetLouisville Laboratories, Inc. · 19981 recall
  • K971802Vaginal Suturing Kit for Bladder Neck SuspensionLouisville Laboratories, Inc. · 1997
  • K971791Vaginal Suturing Kit for Laparotomy Bladder Neck SuspensionLouisville Laboratories, Inc. · 1997
  • K971801Laparotomy Bladder Neck Suspension KitLouisville Laboratories, Inc. · 1997
  • K971797Laparoscopic Bladder Neck Suspension KitLouisville Laboratories, Inc. · 1997

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/K971796 · printed Nov 5, 2026

Cite this page

510(k) Report. “K971796: Laparotomy Bladder Neck Suspension Kit with Bone Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971796

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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