510(k) Report

510(k) · Cleared

Cleared

Vesitec Suture Passer

K931181510(k) TraditionalCleared May 12, 199364-day reviewClass I21 CFR 876.4730

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

Vesitec Medical, Inc. · KOA Surgical Instruments, G-U, Manual (And Accessories)

Cleared on May 12, 1993 after a 64-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
May 12, 1993
Review
64 days
Class
Class I
Product code
KOA
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1998: 1 descendant cleared1990200020102020
  1. This deviceK931181 Vesitec Suture PasserVesitec Medical, Inc. · 1993
  2. Descendant · cites it directly · 1 of its ownK971796 Laparotomy Bladder Neck Suspension Kit with Bone AnchorsLouisville Laboratories, Inc. · 1997
  3. Descendant · 2 generations on · 0 of its ownK982626 Urethropexy Suture Placement Kit Model Numbers UM-300, MW-100…Medworks Corp. · 1998

Most influential descendants

Showing 2 of 2 · See all
  • K971796Laparotomy Bladder Neck Suspension Kit with Bone AnchorsLouisville Laboratories, Inc. · 1997 · cites it directly1descendant
  • K982626Urethropexy Suture Placement Kit Model Numbers UM-300, MW-100, Mini-Laparotomy MMK Kit…Medworks Corp. · 1998 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K931181Vesitec Suture PasserVesitec Medical, Inc.1993—
+1K971796Laparotomy Bladder Neck Suspension Kit with Bone AnchorsLouisville Laboratories, Inc.1997—
+2K982626Urethropexy Suture Placement Kit Model Numbers UM-300, MW-100, Mini-Laparotomy…Medworks Corp.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
FIG. 1 — Lineage of K931181, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KOA? 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K971796Laparotomy Bladder Neck Suspension Kit with Bone AnchorsLouisville Laboratories, Inc.19971

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?

  • Of its descendants, K971796 (Louisville Laboratories, Inc., 1997) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KOA devices

KOA Surgical Instruments, G-U, Manual (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KOA

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KOA

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

Recalls per year · KOA

No recall names KOA since 2007.

Adverse event reports per year · KOA

3in 2025

2007: 12009: 12013: 12016: 22017: 32018: 32019: 22020: 12021: 12023: 52024: 22025: 3
2007high 5 (2023) · low 0 (2008)2025

MAUDE reports naming product code KOA, 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
20070—01
20080—00
20090—01
20100—00
20110—00
20120—00
20130—01
20140—00
20150—00
20160—02
20170—03
20181—03
20190—02
20200—01
20210—01
20220—00
20230—05
20240—02
20250—03
20260—0—

More from Vesitec Medical, Inc.

3 FDA decisions under this applicant name. See the company

  • K932925Bone Anchor for Soft Tissue AttachmentVesitec Medical, Inc. · 19942 recalls
  • K931182Vesitec Drill GuideVesitec Medical, Inc. · 1993

Recent decisions in KOA

The KOA category page

  • K182664FiXcisionAgency For Medical Innovations GmbH · 2018
  • K950267Urethral Suture GuideApplied Medical Resources · 1995
  • K932465LI VasectomyFemcare, Ltd. · 1994
  • K921546Vasovasostomy SetCook Urological, Inc. · 1993
  • K921304DDV LigatorNorth American Medical, Inc. · 1992

https://510kreport.com/device/K931181 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931181: Vesitec Suture Passer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931181

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026