510(k) Report

510(k) · Cleared

Cleared

Uresil Valve Cutter with Interchangeable Heads

K930011510(k) TraditionalCleared May 26, 1993142-day reviewClass II21 CFR 870.4885

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

Uresil Corp. · MGZ Valvulotome

Cleared on May 26, 1993 after a 142-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 26, 1993
Review
142 days
Class
Class II
Product code
MGZ
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared2019: 1 descendant cleared1990200020102020
  1. This deviceK930011 Uresil Valve Cutter with Interchangeable HeadsUresil Corp. · 1993
  2. Descendant · cites it directly · 0 of its ownK190267 EZE SIT ValvulotomeLemaitre Vascular · 2019
  3. Descendant · cites it directly · 0 of its ownK964061 Gore Angioscopic Valvvlotome Kit (TBD)W. L. Gore & Associates, Inc. · 1997

Most influential descendants

Showing 2 of 2 · See all
  • K190267EZE SIT ValvulotomeLemaitre Vascular · 2019 · cites it directly0descendants
  • K964061Gore Angioscopic Valvvlotome Kit (TBD)W. L. Gore & Associates, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930011Uresil Valve Cutter with Interchangeable HeadsUresil Corp.1993—
+1K190267EZE SIT ValvulotomeLemaitre Vascular2019—
+1K964061Gore Angioscopic Valvvlotome Kit (TBD)W. L. Gore & Associates, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
201910
FIG. 1 — Lineage of K930011, 1993–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 MGZ? 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 MGZ device

  1. #1 K260188 LimFlow Vectorscore 11.9 · 4 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?

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)

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

NumberDeviceApplicantDecidedDescendants
K190267EZE SIT ValvulotomeLemaitre Vascular20190
K964061Gore Angioscopic Valvvlotome Kit (TBD)W. L. Gore & Associates, Inc.19970

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, K190267 (Lemaitre Vascular, 2019) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MGZ devices

MGZ Valvulotome: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MGZ

1in 2025

2008: 12011: 12013: 22014: 22019: 12022: 12025: 12026 (partial year): 1
2007high 2 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MGZ

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

Recalls per year · MGZ

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

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

Adverse event reports per year · MGZ

8in 2025

2007: 22009: 32014: 12016: 32017: 212018: 72019: 192020: 62021: 22022: 132023: 232024: 32025: 8
2007high 23 (2023) · low 0 (2008)2025

MAUDE reports naming product code MGZ, 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—02
20081—00
20090—03
20100—00
20111—00
20120—00
20132—00
20142—11
20150—00
20160—03
20170—021
20180—07
20191—019
20200—06
20210—02
20221—013
20230—023
20240—03
20251—08
20261—0—

More from Uresil Corp.

45 FDA decisions under this applicant name. See the company

  • K003753GP General Purpose Drainage Set, Mini-Pigtail Drainage Catheter with Locking Pigtail, GP General Purpose…Uresil Corp. · 2001
  • K980278Uresil Vascu-Flo Infusion CatheterUresil Corp. · 1998
  • K981344Uresil Percutaneous Drainage Catheters with Hydrophilic CoatingUresil Corp. · 1998
  • K980282Uresil Dilator with Radiopaque MarkerUresil Corp. · 1998
  • K980889Uresil Nephro-Ureteral StentUresil Corp. · 1998

Recent decisions in MGZ

The MGZ category page

  • K260188LimFlow VectorLimFlow, Inc. · 2026
  • K250105Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)Aveera Medical, Inc. · 2025
  • K221902LimFlow VectorLimFlow, Inc. · 20221 recall
  • K190267EZE SIT ValvulotomeLemaitre Vascular · 2019
  • K142660Antegrade LeMills ValvulotomeLeMaitre Vascular, Inc. · 2014

https://510kreport.com/device/K930011 · printed Nov 6, 2026

Cite this page

510(k) Report. “K930011: Uresil Valve Cutter with Interchangeable Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930011

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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