510(k) Report

510(k) · Cleared

Cleared

Fujinon Evl-F Video Laproscope

K983561510(k) SpecialCleared Dec 16, 199864-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

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

Cleared on Dec 16, 1998 after a 64-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.

Decided
Dec 16, 1998
Review
64 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2017: 1 descendant cleared2018: 1 descendant cleared2020: 2 descendants cleared2021: 2 descendants cleared2024: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK983561 Fujinon Evl-F Video LaproscopeFujinon, Inc. · 1998
  2. Descendant · cites it directly · 8 of its ownK162836 FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc. · 2017
  3. Descendant · 2 generations on · 6 of its ownK192918 Video Laparoscope, Video Processor, Light SourceFujifilm Corporation · 2020
  4. Descendant · 3 generations on · 3 of its ownK203717 Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton · 2021
  5. Descendant · 4 generations on · 1 of its ownK250268 HyperSnap Surgical System (HSS)Hypervision Surgical · 2025
  6. Descendant · 3 generations on · 1 of its ownK202130 FUJIFILM Video LaparoscopeFujifilm Corporation · 2020

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2017: 12018: 12020: 22021: 22024: 12025: 12026: 1
2017high 2 (2020) · low 0 (2019)2026

Most influential descendants

Showing 5 of 9 · See all
  • K162836FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc. · 2017 · cites it directly8descendants
  • K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation · 2020 · 2 generations on6descendants
  • K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton · 2021 · 3 generations on3descendants
  • K250268HyperSnap Surgical System (HSS)Hypervision Surgical · 2025 · 4 generations on1descendant
  • K202130FUJIFILM Video LaparoscopeFujifilm Corporation · 2020 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K983561Fujinon Evl-F Video LaproscopeFujinon, Inc.1998—
+1K162836FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc.2017—
+2K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation2020—
+3K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton2021—
+4K250268HyperSnap Surgical System (HSS)Hypervision Surgical2025—
+3K202130FUJIFILM Video LaparoscopeFujifilm Corporation2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
202020
202120
202410
202510
202610
FIG. 1 — Lineage of K983561, 1998–2026Source: 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), the FDA 510(k) statement (indications), 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
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K162836FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc.20178

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, K162836 (Fujifilm New Development U.S.A., Inc., 2017) has gone furthest, with 8 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—

What is it indicated for?

The flexible laproscope can be used to view complete therapeutic procedures using approved laproscopic instrumentation. The laproscope is used as a viewing device to complete procedures such as Laprosopic Cholecystectomy: Separation of Adhesions: Tubal Pregnancy: Uterine Hypoplasia: Infertilization: Mtritus: Cervical Myoma.

Also procedures within the Thoracic Cavity such as the diagnosis and staging of Intrathoracic disease, therapeutic thoracic procedures, wedge resections, tube toracistomy plerodesis, thoracoscopy pleurodesis.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Fujinon, Inc.

30 FDA decisions under this applicant name. See the company

  • K120446Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc. · 20121 recall
  • K112391Fujinon ColonoscopesFujinon, Inc. · 2012
  • K102466Fujinon Epx-4440HD Digital Video ProcessorFujinon, Inc. · 2011
  • K111243Fujinon Ultrasonic ProcessorFujinon, Inc. · 2011
  • K091773Fujinon Sterile OvertubesFujinon, Inc. · 2009

Recent decisions in GCJ

The GCJ category page

  • K262455da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci…Intuitive Surgical, Inc. · 2026
  • K262397CuratOR EX2742Eizo Corporation · 2026
  • K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
  • K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation · 2026
  • K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC · 2026

https://510kreport.com/device/K983561 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983561: Fujinon Evl-F Video Laproscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983561

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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