510(k) · Cleared

Cleared

Uromed Sling Kit

K980717510(k) TraditionalCleared May 22, 199887-day reviewClass II21 CFR 884.4530

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

Uromed Corp. · KNA Instrument, Manual, Specialized Obstetric-Gynecologic

Cleared on May 22, 1998 as substantially equivalent to K933698 (Cook Urological, Inc., 1994) and 2 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1988.

Decided: May 22, 1998
Review: 87 days
Class: Class II
Product code: KNA
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K881224 (1988). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK881224 Acufex Suture Retriever, Sterile DisposableAcufex Microsurgical, Inc. · 1988
This deviceK980717 Uromed Sling KitUromed Corp. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K881224	Acufex Suture Retriever, Sterile Disposable	Acufex Microsurgical, Inc.	1988	—
0 (this device)	K980717	Uromed Sling Kit	Uromed Corp.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1994	1	0

FIG. 1 — Lineage of K980717, 1988–1998Source: 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 KNA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (5)

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
*	K933698	100 Series Endoscopic Grasping Forceps Summary page 1 …Sling Kit Classification Name: 21 CFR § 876.4730 Manual Surgical Instruments Predicate Devices used for Substantial Equivalence Device Premarket # Cook Loop Retriever K933698 Cook Stamey Needle Pre-Amendment Cook Fascial Dilator Unknown Acufex Suture Retriever K 881224 and K926036 Intended Use The…	Cook Urological, Inc.	1994	—
*	K881224	Acufex Suture Retriever, Sterile Disposable Summary page 1 …sed for Substantial Equivalence Device Premarket # Cook Loop Retriever K933698 Cook Stamey Needle Pre-Amendment Cook Fascial Dilator Unknown Acufex Suture Retriever K 881224 and K926036 Intended Use The UroMed Sling Kit is intended to be used in a suburethral sling procedure for the alleviation of in…	Acufex Microsurgical, Inc.	1988	—
*	K926036	Acufex Suture Retriever Summary page 1 …antial Equivalence Device Premarket # Cook Loop Retriever K933698 Cook Stamey Needle Pre-Amendment Cook Fascial Dilator Unknown Acufex Suture Retriever K 881224 and K926036 Intended Use The UroMed Sling Kit is intended to be used in a suburethral sling procedure for the alleviation of involuntary le…	Acufex Microsurgical, Inc.	1993	—
*	—	Cook Stamey Needle Named without a submission number			—
*	—	Cook Fascial Dilator Named without a submission number			—

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?

None of the 3 ancestors has a recall.

How does its category compare?

All KNA devices

KNA Instrument, Manual, Specialized Obstetric-Gynecologic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNA

1in 2014

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNA

Too few KNA 510(k)s in any year since 2007 to give a median.

Recalls per year · KNA

No recall names KNA since 2007.

Adverse event reports per year · KNA

5in 2025

2007high 63 (2018) · low 0 (2008)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	2
2008	0	—	0
2009	1	—	0
2010	1	—	8
2011	1	—	13
2012	0	—	8
2013	0	—	2
2014	1	—	4
2015	0	—	8
2016	0	—	22
2017	0	—	37
2018	0	—	63
2019	0	—	5
2020	0	—	0
2021	0	—	2
2022	0	—	4
2023	0	—	2
2024	0	—	1
2025	0	—	5
2026	0	—	—

What is it indicated for?

The UroMed Sling Kit is indicated for use by the surgeon for placing a urethral sling. The kit provides instruments to help the surgeon place the sling beneath the urethra. The kit will be used in suburethral sling procedures for female urinary incontinence due to urethral hypermobility and/or intrinsic sphincter deficiency.

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/K980717 · printed Nov 5, 2026

Cite this page

510(k) Report. “K980717: Uromed Sling Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980717

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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