510(k) · Cleared

Cleared

Vaginal Suturing Kit for Laparotomy Bladder Neck Suspension

K971791510(k) TraditionalCleared Jul 30, 199776-day reviewClass II21 CFR 888.3040

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

Louisville Laboratories, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Jul 30, 1997 as substantially equivalent to K963076 (Louisville Laboratories, Inc., 1997) and 1 other predicate after a 76-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided: Jul 30, 1997
Review: 76 days
Class: Class II
Product code: MBI
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 deviceK971791 Vaginal Suturing Kit for Laparotomy Bladder Neck SuspensionLouisville 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)	K971791	Vaginal Suturing Kit for Laparotomy Bladder Neck Suspension	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 K971791, 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 MBI? 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 MBI device

#1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 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 …Neck Suspension 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. 5/14/97 Page D-1 V…	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 MBI devices

MBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MBI

27in 2025

2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

2007high 24 (2007) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MBI

3,826in 2025

2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, 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	16	80	24	240
2008	10	69	6	338
2009	19	82	2	355
2010	17	76	3	291
2011	30	75	23	328
2012	24	94	6	371
2013	31	100	2	442
2014	23	101	0	504
2015	23	85	0	507
2016	17	94	0	795
2017	17	70	4	675
2018	16	91	2	1,072
2019	31	90	0	1,303
2020	35	83	1	1,454
2021	18	107	0	1,890
2022	19	64	0	1,591
2023	52	57	1	2,503
2024	22	30	1	3,779
2025	27	58	1	3,826
2026	30	63	0	—

What is it indicated for?

The Louisville Laboratories, Inc. Vaginal Suturing Kit for Laparotomy Bladder Neck Suspension 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/K971791 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971791: Vaginal Suturing Kit for Laparotomy Bladder Neck Suspension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971791

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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