510(k) Report

510(k) · Cleared

Cleared

Viaduct Microendoscope and Accessories

K011189510(k) TraditionalCleared Jul 16, 200189-day reviewClass II21 CFR 876.1500

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

Acueity, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Jul 16, 2001 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 43 later devices descend from it.

Decided
Jul 16, 2001
Review
89 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
0

43 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2010: 4 descendants cleared2002: 1 descendant cleared2006: 2 descendants cleared2004: 2 descendants cleared2005: 1 descendant cleared2009: 2 descendants cleared2008: 2 descendants cleared2011: 2 descendants cleared2015: 4 descendants cleared2014: 2 descendants cleared2019: 4 descendants cleared2012: 2 descendants cleared2018: 2 descendants cleared2021: 3 descendants cleared2026: 2 descendants cleared2016: 2 descendants cleared2024: 2 descendants cleared2017: 1 descendant cleared2020: 1 descendant cleared2022: 2 descendants cleared200020052010201520202025
  1. This deviceK011189 Viaduct Microendoscope and AccessoriesAcueity, Inc. · 2001
  2. Descendant · cites it directly · 37 of its ownK020310 Davlite Microendoscope & AccessoriesDavlite Technologies · 2002
  3. Descendant · 2 generations on · 31 of its ownK040604 Innervue Diagnostic Scope SystemArthrotek, Inc. · 2004
  4. Descendant · 3 generations on · 30 of its ownK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
  5. Descendant · 2 generations on · 21 of its ownK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
  6. Descendant · 3 generations on · 16 of its ownK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

2002: 12004: 22005: 12006: 22008: 22009: 22010: 42011: 22012: 22014: 22015: 42016: 22017: 12018: 22019: 42020: 12021: 32022: 22024: 22026: 2
2002high 4 (2010) · low 0 (2003)2026

Most influential descendants

Showing 5 of 43 · See all
  • K020310Davlite Microendoscope & AccessoriesDavlite Technologies · 2002 · cites it directly37descendants
  • K040604Innervue Diagnostic Scope SystemArthrotek, Inc. · 2004 · 2 generations on31descendants
  • K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · 3 generations on30descendants
  • K082293Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008 · 2 generations on21descendants
  • K093717C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010 · 3 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011189Viaduct Microendoscope and AccessoriesAcueity, Inc.2001—
+1K020310Davlite Microendoscope & AccessoriesDavlite Technologies2002—
+2K040604Innervue Diagnostic Scope SystemArthrotek, Inc.2004—
+3K072879Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc.20082
+2K082293Surgview Integrated Visualization SystemBiovision Technologies, LLC2008—
+3K093717C-Mor Visualization DeviceAxis Surgical Technologies, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200420
200510
200620
200820
200920
201040
201120
201220
201420
201540
201620
201710
201820
201940
202010
202130
202220
202420
202620
FIG. 1 — Lineage of K011189, 2001–2026Source: 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 GCJ? 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 GCJ device

  1. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (43)

See all 43

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

NumberDeviceApplicantDecidedDescendants
K020310Davlite Microendoscope & AccessoriesDavlite Technologies200237
K063078MicroendoscopeAcclarent, Inc.20062
K051073Midiview Series of MicroendoscopesMillennium Devices, Inc.20062
K092739Microendoscope Model S-0001 Single Light Source, Microendoscope, Model D-0001 Dual Light…C-Link Micro Imaging, Inc.20100
K050650Novacyte Microendoscope and Accessories, Models NC1000;NCAM1000Cytyc Surgical Products20050
K040949Viaduct Miniscope and AccessoriesAcueity, Inc.20040

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, K020310 (Davlite Technologies, 2002) has gone furthest, with 37 descendants of its own.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, 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
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

More from Acueity, Inc.

4 FDA decisions under this applicant name. See the company

  • K040949Viaduct Miniscope and AccessoriesAcueity, Inc. · 2004
  • K032847Excisor Bioptome, Model 01-0004Acueity, Inc. · 2003
  • K032430Acueity Medical Light SourceAcueity, Inc. · 2003

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https://510kreport.com/device/K011189 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011189: Viaduct Microendoscope and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011189

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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