510(k) Report

510(k) · Cleared

Cleared

Surgical Vascular Clamp

K973080510(k) TraditionalCleared Feb 23, 1998189-day reviewClass II21 CFR 870.4450

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

Walter Lorenz Surgical, Inc. · DXC Clamp, Vascular

Cleared on Feb 23, 1998 after a 189-day review. The FDA summary names no predicate by number. 11 later devices descend from it.

Decided
Feb 23, 1998
Review
189 days
Class
Class II
Product code
DXC
Recalls
None
Predicates
0

11 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2008: 1 descendant cleared2009: 1 descendant cleared2004: 1 descendant cleared2013: 2 descendants cleared2011: 1 descendant cleared2012: 2 descendants cleared2021: 1 descendant cleared1995200020052010201520202025
  1. This deviceK973080 Surgical Vascular ClampWalter Lorenz Surgical, Inc. · 1998
  2. Descendant · cites it directly · 7 of its ownK072834 Sibel SA Vascular ClampSurgical Instruments Belgium SA · 2008
  3. Descendant · 2 generations on · 3 of its ownK110148 Wexler Vascular Clamp SeriesMicrosurgical Laboratories,Inc.Dba Wexler Surgical · 2011
  4. Descendant · cites it directly · 2 of its ownK011863 VCS-a Series ClampVascular Control Systems, Inc. · 2002
  5. Descendant · 3 generations on · 1 of its ownK123571 Cardio Vision Mics Aortic ClampsCardiomedical GmbH · 2013
  6. Descendant · cites it directly · 1 of its ownK092544 Instrumed Vascular ClampsInstrumed International, Inc. · 2009

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2002: 22004: 12008: 12009: 12011: 12012: 22013: 22021: 1
2002high 2 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 11 · See all
  • K072834Sibel SA Vascular ClampSurgical Instruments Belgium SA · 2008 · cites it directly7descendants
  • K110148Wexler Vascular Clamp SeriesMicrosurgical Laboratories,Inc.Dba Wexler Surgical · 2011 · 2 generations on3descendants
  • K011863VCS-a Series ClampVascular Control Systems, Inc. · 2002 · cites it directly2descendants
  • K123571Cardio Vision Mics Aortic ClampsCardiomedical GmbH · 2013 · 3 generations on1descendant
  • K092544Instrumed Vascular ClampsInstrumed International, Inc. · 2009 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K973080Surgical Vascular ClampWalter Lorenz Surgical, Inc.1998—
+1K072834Sibel SA Vascular ClampSurgical Instruments Belgium SA2008—
+2K110148Wexler Vascular Clamp SeriesMicrosurgical Laboratories,Inc.Dba Wexler Surgical2011—
+1K011863VCS-a Series ClampVascular Control Systems, Inc.2002—
+3K123571Cardio Vision Mics Aortic ClampsCardiomedical GmbH2013—
+1K092544Instrumed Vascular ClampsInstrumed International, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200410
200810
200910
201110
201220
201320
202110
FIG. 1 — Lineage of K973080, 1998–2021Source: 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), 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 DXC? 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 DXC device

  1. #1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 7 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?

The FDA summary names no predicate by number.

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K072834Sibel SA Vascular ClampSurgical Instruments Belgium SA20087
K011863VCS-a Series ClampVascular Control Systems, Inc.20022
K092544Instrumed Vascular ClampsInstrumed International, Inc.20091
K023154VCS-a Series Clamp with Doppler Ultrasound, Model 09-0007-01 and 09-0007-02Vascular Control Systems, Inc.20021

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, K072834 (Surgical Instruments Belgium SA, 2008) has gone furthest, with 7 descendants of its own.

How does its category compare?

All DXC devices

DXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXC

2in 2025

2007: 102008: 32009: 42010: 22011: 62012: 52013: 142014: 42015: 52016: 32017: 32018: 22019: 22020: 32021: 62022: 12023: 42024: 12025: 22026 (partial year): 4
2007high 14 (2013) · low 1 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXC

215in 2023

2007: 52 days median2008: 29 days median2009: 83 days median2011: 51 days median2012: 73 days median2013: 89 days median2014: 157 days median2015: 71 days median2016: 91 days median2017: 90 days median2020: 209 days median2021: 37 days median2023: 215 days median2026 (partial year): 125 days median
2007high 215 (2023) · low 29 (2008)2026

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

Recalls per year · DXC

2in 2023

2008: 22009: 22010: 12011: 32014: 12022: 12023: 2
2007high 3 (2011) · low 0 (2007)2026

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

Adverse event reports per year · DXC

442in 2025

2007: 2982008: 3022009: 5392010: 6002011: 6912012: 5482013: 9202014: 4942015: 3742016: 4942017: 4162018: 3912019: 3932020: 4042021: 3712022: 2732023: 6742024: 3752025: 442
2007high 920 (2013) · low 273 (2022)2025

MAUDE reports naming product code DXC, 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
200710520298
20083292302
20094832539
20102—1600
20116513691
20125730548
201314890920
201441571494
20155710374
20163910494
20173900416
20182—0391
20192—0393
202032090404
20216370371
20221—1273
202342152674
20241—0375
20252—0442
202641250—

What is it indicated for?

These devices are for temporary occlusion of blood vessels during vascular surgical procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K973080: Surgical Vascular Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973080

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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