510(k) Report

510(k) · Cleared

Cleared

Karl Storz Video Gastroscopes

K060907510(k) TraditionalCleared Nov 9, 2006220-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

KARL STORZ Endoscopy-America, Inc. · FDS Gastroscope And Accessories, Flexible/Rigid

Cleared on Nov 9, 2006 after a 220-day review. The FDA summary names no predicate by number. 97 later devices descend from it.

Decided
Nov 9, 2006
Review
220 days
Class
Class II
Product code
FDS
Recalls
None
Predicates
0

97 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2014: 2 descendants cleared2010: 1 descendant cleared2012: 2 descendants cleared2016: 2 descendants cleared2015: 2 descendants cleared2017: 7 descendants cleared2019: 7 descendants cleared2020: 14 descendants cleared2018: 8 descendants cleared2023: 7 descendants cleared2021: 9 descendants cleared2025: 8 descendants cleared2022: 14 descendants cleared2024: 8 descendants cleared2026: 6 descendants cleared20052010201520202025
  1. This deviceK060907 Karl Storz Video GastroscopesKARL STORZ Endoscopy-America, Inc. · 2006
  2. Descendant · cites it directly · 85 of its ownK141093 6VT-D Ultrasound TransducerGe Vingmed Ultrasound AS · 2014
  3. Descendant · 2 generations on · 84 of its ownK142323 Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic…Ge Medical Systems Israel, Ltd. · 2014 · Recalled
  4. Descendant · 3 generations on · 73 of its ownK150087 Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic…Ge Vingmed Ultrasound AS · 2015 · Recalled
  5. Descendant · 4 generations on · 46 of its ownK161706 Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L · 2016
  6. Descendant · 3 generations on · 35 of its ownK170714 VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017

Showing 5 of 97 descendants. See all descendants

Descendants cleared per year

2010: 12012: 22014: 22015: 22016: 22017: 72018: 82019: 72020: 142021: 92022: 142023: 72024: 82025: 82026: 6
2010high 14 (2020) · low 0 (2011)2026

Most influential descendants

Showing 5 of 97 · See all
  • K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS · 2014 · cites it directly85descendants
  • K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd. · 2014 · 2 generations on84descendants
  • K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging…Ge Vingmed Ultrasound AS · 2015 · 3 generations on73descendants
  • K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L · 2016 · 4 generations on46descendants
  • K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017 · 3 generations on35descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K060907Karl Storz Video GastroscopesKARL STORZ Endoscopy-America, Inc.2006—
+1K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS2014—
+2K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd.20143
+3K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic…Ge Vingmed Ultrasound AS20156
+4K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L2016—
+3K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201220
201420
201520
201620
201770
201880
201970
2020140
202190
2022140
202370
202480
202580
202660
FIG. 1 — Lineage of K060907, 2006–2026Source: 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), 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 16.5 · 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?

The FDA summary names no predicate by number.

What descends from it? (97)

See all 97

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

NumberDeviceApplicantDecidedDescendants
K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS201485
K093779Clearpath UgiEasyglide, Ltd.201010

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, K141093 (Ge Vingmed Ultrasound AS, 2014) has gone furthest, with 85 descendants of its own.

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.

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?

The Karl Storz Video Gastroscope System is intended to be used by physician / endoscopist in the visual examination and treatment of the upper digestive tract including the esophagus, stomach, and duodenum. The Video-Gastroscope System is intended to provide optical visualization via a video monitor and therapeutic access to the upper digestive tract.

Indications for use as stated in the FDA summary.

More from KARL STORZ Endoscopy-America, Inc.

381 FDA decisions under this applicant name. See the company

  • P050027/S038Photodynamic Diagnostic D-Light C SystemKARL STORZ Endoscopy-America, Inc. · 2026
  • P050027/S036Photodynamic Diagnostic D-Light C SystemKARL STORZ Endoscopy-America, Inc. · 2026
  • K252624KARL STORZ Laryngoscopes and AccessoriesKARL STORZ Endoscopy-America, Inc. · 2026
  • P050027/S035Photodynamic Diagnostic D-Light C (PDD) SystemKARL STORZ Endoscopy-America, Inc. · 2026
  • P050027/S034Photodynamic Diagnostic D-Light C SystemKARL STORZ Endoscopy-America, Inc. · 2025

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/K060907 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060907: Karl Storz Video Gastroscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060907

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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