510(k) · Cleared
ClearedFUJIFILM Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm New Development U.S.A., Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Mar 13, 2017 as substantially equivalent to K983561 (Fujinon, Inc., 1998) and 1 other predicate after a 153-day review. Its family tree reaches back 9 generations to 1993. 3 of the 41 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- Mar 13, 2017
- Review
- 153 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K931154 (1993). 32 ancestors in all, the oldest K843084 (1985). 8 later devices descend from it, 2 citing it directly. 3 of the 41 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 5 generations between
- 3 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 2 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 1 generation backK140149 Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc. · 2014
- This deviceK162836 FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc. · 2017
- Descendant · cites it directly · 6 of its ownK192918 Video Laparoscope, Video Processor, Light SourceFujifilm Corporation · 2020
- Descendant · 2 generations on · 3 of its ownK203717 Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton · 2021
- Descendant · 3 generations on · 1 of its ownK250268 HyperSnap Surgical System (HSS)Hypervision Surgical · 2025
- Descendant · 2 generations on · 1 of its ownK202130 FUJIFILM Video LaparoscopeFujifilm Corporation · 2020
- Descendant · 4 generations on · 0 of its ownK253984 Instrument Exit Point on Touch Surgery™ AideCovidien, LLC · 2026
Show all 9 generations
- Root · 9 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 8 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 7 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 6 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 5 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 4 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 3 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 2 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 1 generation backK140149 Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc. · 2014
- This deviceK162836 FUJIFILM Surgical SystemFujifilm New Development U.S.A., Inc. · 2017
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation · 2020 · cites it directly6descendants
- K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Fujifilm Corporaton · 2021 · 2 generations on3descendants
- K250268HyperSnap Surgical System (HSS)Hypervision Surgical · 2025 · 3 generations on1descendant
- K202130FUJIFILM Video LaparoscopeFujifilm Corporation · 2020 · 2 generations on1descendant
- K253984Instrument Exit Point on Touch Surgery™ AideCovidien, LLC · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −8 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −7 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −6 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −5 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −4 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −3 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −2 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| −1 | K140149 | Epx-4440HD Digital Video Processor | Fujifilm Medical Systems U.S.A, Inc. | 2014 | — |
| 0 (this device) | K162836 | FUJIFILM Surgical System | Fujifilm New Development U.S.A., Inc. | 2017 | — |
| +1 | K192918 | Video Laparoscope, Video Processor, Light Source | Fujifilm Corporation | 2020 | — |
| +2 | K203717 | Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 | Fujifilm Corporaton | 2021 | — |
| +3 | K250268 | HyperSnap Surgical System (HSS) | Hypervision Surgical | 2025 | — |
| +2 | K202130 | FUJIFILM Video Laparoscope | Fujifilm Corporation | 2020 | — |
| +4 | K253984 | Instrument Exit Point on Touch Surgery™ Aide | Covidien, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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.
3 devices in this family have a Class I recall. 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 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K983561 | Fujinon Evl-F Video LaproscopeSummary page 4…deo Processor Classification Name Endoscope and Accessories; 21 C.F.R. 876.1500 Class II Product Code: GCJ Predicate Devices Fujinon, Inc. EL2-TF410 Video Laparoscope (K983561) FUJIFILM Corp. EPX-4440 HD Digital Video Processor with FICE (K140149) Device Description The FUJIFILM Surgical System is compr… | 1998 |
| * | K140149 | Epx-4440HD Digital Video ProcessorSummary page 4…876.1500 Class II Product Code: GCJ Predicate Devices Fujinon, Inc. EL2-TF410 Video Laparoscope (K983561) FUJIFILM Corp. EPX-4440 HD Digital Video Processor with FICE (K140149) Device Description The FUJIFILM Surgical System is comprised of: • EL-580FN Video Laproscope with RC-4440FN Relay Connector… | 2014 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 3 generations back · ◆ on the line of descent in FIG. 16 Class I recalls
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 5 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 17 of the 32 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K192918 (Fujifilm Corporation, 2020) has gone furthest, with 6 descendants of its own.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The FUJIFILM Surgical System includes a laparoscope, video processor and light source and is intended to be used with a monitor, hand instruments, electrosurgical unit, and other ancillary equipment for minimally invasive laparoscopic observation, diagnosis and treatment in general abdominal and gynecologic areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162836 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162836: FUJIFILM Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162836
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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