510(k) · Cleared

Cleared

Laparoscopic Bladder Neck Suspension Kit

K971797510(k) TraditionalCleared Jul 22, 199768-day reviewClass II21 CFR 884.1720

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

Louisville Laboratories, Inc. · HET Laparoscope, Gynecologic (And Accessories)

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. 5 later devices descend from it.

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

Its longest line of descent runs back 1 generation to K932553 (1994). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK932553 Disposable Suture Placement SystemLaurus Medical Corp. · 1994 · Recalled
This deviceK971797 Laparoscopic Bladder Neck Suspension KitLouisville Laboratories, Inc. · 1997
Descendant · cites it directly · 3 of its ownK011190 Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc. · 2002
Descendant · 2 generations on · 2 of its ownK020126 Modification to Surx Radiofrequency Electrosurgical Generator System…Surx, Inc. · 2002
Descendant · 2 generations on · 1 of its ownK020952 Surx RF SystemSurx, Inc. · 2002
Descendant · 3 generations on · 0 of its ownK042132 Novasys Transurethral RF SystemNovasys Medical, Inc. · 2004 · Recalled
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 5 of 5 · See all

K011190Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System)Surx, Inc. · 2002 · cites it directly3descendants
K020126Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc. · 2002 · 2 generations on2descendants
K020952Surx RF SystemSurx, Inc. · 2002 · 2 generations on1descendant
K042132Novasys Transurethral RF SystemNovasys Medical, Inc. · 2004 · 3 generations on0descendants
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)	K971797	Laparoscopic Bladder Neck Suspension Kit	Louisville Laboratories, Inc.	1997	—
+1	K011190	Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP…	Surx, Inc.	2002	—
+2	K020126	Modification to Surx Radiofrequency Electrosurgical Generator System and…	Surx, Inc.	2002	—
+2	K020952	Surx RF System	Surx, Inc.	2002	—
+3	K042132	Novasys Transurethral RF System	Novasys Medical, Inc.	2004	1
+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
2002	3	0
2004	1	0

FIG. 1 — Lineage of K971797, 1994–2004Source: 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 HET? 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 HET device

#1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

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 2 …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 2 …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. Laparoscopic Suspe…	Laurus Medical Corp.	1994	2
*	—	surgical techniques that have been performed for over forty years Named without a submission number			—

Also cleared against K963076: 5 other devices →

What descends from it? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K011190	Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System)	Surx, Inc.	2002	3
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, K011190 (Surx, Inc., 2002) has gone furthest, with 3 descendants of its own.
5 other devices also cite its predicate K963076.

How does its category compare?

All HET devices

HET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HET

2in 2025

2007high 4 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HET

269in 2021

2007high 269 (2021) · low 176 (2008)2026

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

Recalls per year · HET

4in 2023

2007high 4 (2008) · low 0 (2007)2026

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

Adverse event reports per year · HET

4,513in 2025

2007high 4,513 (2025) · low 44 (2019)2025

MAUDE reports naming product code HET, 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	0	—	0	181
2008	3	176	4	359
2009	1	—	1	403
2010	1	—	0	214
2011	2	—	0	417
2012	2	—	0	1,118
2013	2	—	0	1,035
2014	0	—	0	175
2015	2	—	1	124
2016	0	—	0	205
2017	2	—	0	89
2018	1	—	0	53
2019	2	—	0	44
2020	2	—	0	49
2021	4	269	0	132
2022	1	—	1	216
2023	0	—	4	824
2024	0	—	0	3,496
2025	2	—	0	4,513
2026	0	—	0	—

What is it indicated for?

The Louisville Laboratories, Inc. Laparoscopic 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/K971797 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971797: Laparoscopic 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/K971797

Report an extraction error

Are you the manufacturer?

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