510(k) Report

510(k) · Cleared

Cleared

FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603

K172916510(k) TraditionalCleared Mar 1, 2018157-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

Fujifilm Corporation · FDS Gastroscope And Accessories, Flexible/Rigid

Cleared on Mar 1, 2018 as substantially equivalent to K132210 (Fujifilm Medical Systems U.S.A, Inc., 2014) and 1 other predicate after a 157-day review. Its family tree reaches back 5 generations to 1995. 18 later devices descend from it.

Decided
Mar 1, 2018
Review
157 days
Class
Class II
Product code
FDS
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K944759 (1995). 7 ancestors in all. 18 later devices descend from it, 11 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1995: 1 other ancestor2023: 4 descendants cleared2020: 2 descendants cleared2025: 4 descendants cleared2019: 4 descendants cleared2024: 3 descendants cleared2026: 1 descendant clearedReference device: K011151 · Evis Exera Gastrointestinal Videoscope Gif-Q160Z · The Olympus Optical Co. · 2001 · recalledReference device: K112680 · Evis Exera Iii Video System · Olympus Medical Systems Corporation · 2012 · recalledK944759 · 200 Series Gastro-Intestinal Video System · Fujinon, Inc. · 1995 · recalledK041903 · Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5 · Fujinon, Inc. · 2004 · recalledK112391 · Fujinon Colonoscopes · Fujinon, Inc. · 2012K132210 · Fujifilm 600 Series Endoscopes · Fujifilm Medical Systems U.S.A, Inc. · 2014K160196 · Fujifilm Video Colonoscope Model EC-600WL V2 · Fujifilm Medical Systems U.S.A, Inc. · 20161995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors 1 generation forward: 11 descendants2 generations forward: 6 descendants3 generations forward: 1 descendant K160196 · Fujifilm Video Colonoscope Model EC-600WL V2 · Fujifilm Medical Systems U.S.A, Inc. · 2016K132210 · Fujifilm 600 Series Endoscopes · Fujifilm Medical Systems U.S.A, Inc. · 2014K112391 · Fujinon Colonoscopes · Fujinon, Inc. · 2012K041903 · Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5 · Fujinon, Inc. · 2004 · recalledK944759 · 200 Series Gastro-Intestinal Video System · Fujinon, Inc. · 1995 · recalled−50
  1. Root · 5 generations backK944759 200 Series Gastro-Intestinal Video SystemFujinon, Inc. · 1995 · Recalled
  2. 4 generations backK041903 Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Fujinon, Inc. · 2004 · Recalled
  3. 3 generations backK112391 Fujinon ColonoscopesFujinon, Inc. · 2012
  4. 2 generations backK132210 Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc. · 2014
  5. 1 generation backK160196 Fujifilm Video Colonoscope Model EC-600WL V2Fujifilm Medical Systems U.S.A, Inc. · 2016
  6. This deviceK172916 FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and…Fujifilm Corporation · 2018
  7. Descendant · cites it directly · 5 of its ownK183572 FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/LFujifilm Corporation · 2019
  8. Descendant · cites it directly · 4 of its ownK182836 FUJIFILM Endoscope Model EG-740NFujifilm Corporation · 2019
  9. Descendant · cites it directly · 3 of its ownK240142 FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T…Fujifilm Corporation · 2024
  10. Descendant · cites it directly · 3 of its ownK232329 Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700…Medivators (A Subsidiary of Steris Corporation) · 2023
  11. Descendant · cites it directly · 3 of its ownK190649 FUJIFILM Endoscope Model EC-760S-V/LFujifilm Corporation · 2019

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2019: 42020: 22023: 42024: 32025: 42026: 1
2019high 4 (2019) · low 0 (2021)2026

Most influential descendants

Showing 5 of 18 · See all
  • K183572FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/LFujifilm Corporation · 2019 · cites it directly5descendants
  • K182836FUJIFILM Endoscope Model EG-740NFujifilm Corporation · 2019 · cites it directly4descendants
  • K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope…Fujifilm Corporation · 2024 · cites it directly3descendants
  • K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water…Medivators (A Subsidiary of Steris Corporation) · 2023 · cites it directly3descendants
  • K190649FUJIFILM Endoscope Model EC-760S-V/LFujifilm Corporation · 2019 · cites it directly3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K944759200 Series Gastro-Intestinal Video SystemFujinon, Inc.19955
−4K041903Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Fujinon, Inc.20041
−3K112391Fujinon ColonoscopesFujinon, Inc.2012—
−2K132210Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc.2014—
−1K160196Fujifilm Video Colonoscope Model EC-600WL V2Fujifilm Medical Systems U.S.A, Inc.2016—
0 (this device)K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and…Fujifilm Corporation2018—
+1K183572FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/LFujifilm Corporation2019—
+1K182836FUJIFILM Endoscope Model EG-740NFujifilm Corporation2019—
+1K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM…Fujifilm Corporation2024—
+1K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use…Medivators (A Subsidiary of Steris Corporation)2023—
+1K190649FUJIFILM Endoscope Model EC-760S-V/LFujifilm Corporation2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201940
202020
202340
202430
202540
202610
FIG. 1 — Lineage of K172916, 1995–2026Source: 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 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 FDS? 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 FDS device

  1. #1 K251708 EvoEndo Single-Use Endoscopy Systemscore 16.4 · 12 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K132210Fujifilm 600 Series Endoscopes
Summary page 4
…ope And Accessories, Flexible/Rigid 21 CFR 876.1500 FDF Predicate Devices • Fujifilm 600 Series Endoscope Model EG-600WR and Water Tank Model WT-4 (K132210) • Fujifilm Video Colonoscope Model EC-600WL v2 (K160196)…
Fujifilm Medical Systems U.S.A, Inc.2014—
*K160196Fujifilm Video Colonoscope Model EC-600WL V2
Summary page 4
…Predicate Devices • Fujifilm 600 Series Endoscope Model EG-600WR and Water Tank Model WT-4 (K132210) • Fujifilm Video Colonoscope Model EC-600WL v2 (K160196) K172916…
Fujifilm Medical Systems U.S.A, Inc.2016—
†K011151Evis Exera Gastrointestinal Videoscope Gif-Q160ZThe Olympus Optical Co.20011
†K112680Evis Exera Iii Video SystemOlympus Medical Systems Corporation20126

Also cleared against K132210: 3 other devices →

What descends from it? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K183572FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/LFujifilm Corporation20195
K182836FUJIFILM Endoscope Model EG-740NFujifilm Corporation20194
K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope…Fujifilm Corporation20243
K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water…Medivators (A Subsidiary of Steris Corporation)20233
K190649FUJIFILM Endoscope Model EC-760S-V/LFujifilm Corporation20193
K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation20251
K200495Andorate Disposable Air/Water Valve, Andorate Disposable Suction ValveGa Health Company Limited20201
K243261FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…Fujifilm Corporation20250
K232028Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base…Iq Endoscopes Limited20230
K200388Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer ConnectorGa Health Company Limited20200

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?

  • The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
  • 3 of the 7 ancestors have a recall of any class.
  • Of its descendants, K183572 (Fujifilm Corporation, 2019) has gone furthest, with 5 descendants of its own.
  • 3 other devices also cite its predicate K132210.

How does its category compare?

All FDS devices

FDS Gastroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · FDS

8in 2025

2007: 22010: 12011: 12012: 32013: 22014: 22015: 22016: 12017: 12018: 62019: 52020: 22021: 52022: 22023: 32024: 52025: 82026 (partial year): 7
2007high 8 (2025) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDS

211in 2025

2012: 181 days median2018: 167 days median2019: 175 days median2021: 78 days median2023: 133 days median2024: 220 days median2025: 211 days median2026 (partial year): 164 days median
2007high 220 (2024) · low 78 (2021)2026

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

Recalls per year · FDS

2in 2024

2013: 12016: 12020: 22024: 2
2007high 2 (2020) · low 0 (2007)2026

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

Adverse event reports per year · FDS

18,905in 2025

2007: 272008: 112009: 212010: 452011: 362012: 352013: 82014: 232015: 292016: 1082017: 1782018: 3042019: 1,3762020: 6012021: 1,7552022: 6,2162023: 9,8742024: 9,2582025: 18,905
2007high 18,905 (2025) · low 8 (2013)2025

MAUDE reports naming product code FDS, 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
20072—027
20080—011
20090—021
20101—045
20111—036
20123181035
20132—18
20142—023
20152—029
20161—1108
20171—0178
201861670304
2019517501,376
20202—2601
202157801,755
20222—06,216
2023313309,874
2024522029,258
20258211018,905
202671640—

What is it indicated for?

FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L have following indications for use. FUJIFILM Endoscope Models EG-760R and EG-760Z are upper gastrointestinal endoscopes intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. FUJIFILM Endoscope Models EC-760R-V/L and EC-760ZP-V/L are lower gastrointestinal endoscopes…

Read the full statement (132 words)

FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L have following indications for use.

FUJIFILM Endoscope Models EG-760R and EG-760Z are upper gastrointestinal endoscopes intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

FUJIFILM Endoscope Models EC-760R-V/L and EC-760ZP-V/L are lower gastrointestinal endoscopes intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. .

FUJIFILM Water Tank Model WT-603 has following indications for use.

The Water Tank Model WT-603 is intended for use in combination with FUJIFILM 700 system scopes to deliver air and water through the endoscope under the management of a physician in medical facilities. Do not use this product for any other purpose.

Indications for use as stated in the FDA summary.

Also cleared against K132210

3 other devices cite the same predicate.

  • K180341FUJIFILM 600 Series Endoscope EG-600WR v2Fujifilm Corporation · 2018
  • K160196Fujifilm Video Colonoscope Model EC-600WL V2Fujifilm Medical Systems U.S.A, Inc. · 2016
  • K143732FUJIFILM Endoscope Models EC-600HL and EC-600LSFujifilm Medical Systems U.S.A, Inc. · 2015

More from Fujifilm Corporation

71 FDA decisions under this applicant name. See the company

  • K262902ECHELON SynergyFujifilm Corporation · 2026
  • K261229SCENARIA View Phase 6.0Fujifilm Corporation · 2026
  • K261283APERTO Lucent MRI SystemFujifilm Corporation · 2026
  • K253836FCT iStream Phase 2Fujifilm Corporation · 2026
  • K261170BA-004CCFujifilm Corporation · 2026

Recent decisions in FDS

The FDS category page

  • K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S · 2026
  • K260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems Corporation · 2026
  • K260856Disposable Distal Attachment D-201-13404Olympus Medical Systems Corporation · 2026
  • K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc. · 2026
  • K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2026

https://510kreport.com/device/K172916 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172916: FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172916

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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