510(k) · Cleared
ClearedMedical Video Endoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhuhai Pusen Medical Technology Co., Ltd. · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on Aug 31, 2017 as substantially equivalent to K131369 (KARL STORZ Endoscopy-America, Inc., 2013) after a 51-day review. Its family tree reaches back 8 generations to 1993. 1 of the 48 devices in its family, counting itself, has a Class I recall. 23 later devices descend from it.
- Decided
- Aug 31, 2017
- Review
- 51 days
- Class
- Class II
- Product code
- FGB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K931154 (1993). 24 ancestors in all, the oldest K843084 (1985). 23 later devices descend from it, 13 citing it directly. 1 of the 48 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 7 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 6 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 5 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 4 generations backK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- 3 generations backK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- 2 generations backK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- 1 generation backK131369 Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
- This deviceK172098 Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK221158 Single-Use Video Flexible Ureterorenoscope SystemGuangzhou Red Pine Medical Instrument Co., Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK230475 Medical Video Endoscope SystemHuger Medical Instrument Co., Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK230200 Single-Use Flexible UreteroscopeHunan Vathin Medical Instrument Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK251951 Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3…Guangzhou Red Pine Medical Instrument Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK243708 Urology Videoscope System (Single-use Flexible Ureteroscope…Scivita Medical Technology Co., Ltd. · 2025
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope6 generations back · 1991
Most influential descendants
Showing 5 of 23 · See all- K221158Single-Use Video Flexible Ureterorenoscope SystemGuangzhou Red Pine Medical Instrument Co., Ltd. · 2023 · cites it directly3descendants
- K230475Medical Video Endoscope SystemHuger Medical Instrument Co., Ltd. · 2023 · cites it directly2descendants
- K230200Single-Use Flexible UreteroscopeHunan Vathin Medical Instrument Co., Ltd. · 2023 · cites it directly2descendants
- K251951Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9…Guangzhou Red Pine Medical Instrument Co., Ltd. · 2025 · 2 generations on1descendant
- K243708Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P…Scivita Medical Technology Co., Ltd. · 2025 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −7 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −6 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −5 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −4 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| −3 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| −2 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| −1 | K131369 | Flexible Video-Uretero-Renoscope System | KARL STORZ Endoscopy-America, Inc. | 2013 | 1 |
| 0 (this device) | K172098 | Medical Video Endoscope System | Zhuhai Pusen Medical Technology Co., Ltd. | 2017 | — |
| +1 | K221158 | Single-Use Video Flexible Ureterorenoscope System | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2023 | — |
| +1 | K230475 | Medical Video Endoscope System | Huger Medical Instrument Co., Ltd. | 2023 | — |
| +1 | K230200 | Single-Use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. | 2023 | — |
| +2 | K251951 | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3… | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025 | — |
| +1 | K243708 | Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B… | Scivita Medical Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1991 | 2 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 10 | 0 |
| 2026 | 4 | 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.
1 device in this family has 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 FGB device
- #1 K251951 Single-Use Video Flexible Ureterorenoscope…score 16.2 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K131369 | Flexible Video-Uretero-Renoscope SystemSummary page 5…name: Ureteroscope and Accessories, Flexible/rigid Classification: Endoscope and accessories. 21 CFR 876.1500. Class II Premarket Notification: Storz K131369 F. Device description: The Medical Video Endoscope system is designed to provide image solution for endoscopy and… | 2013 |
What descends from it? (23)
See all 2313 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221158 | Single-Use Video Flexible Ureterorenoscope System | 2023 | 3 |
| K230475 | Medical Video Endoscope System | 2023 | 2 |
| K230200 | Single-Use Flexible Ureteroscope | 2023 | 2 |
| K243708 | Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P… | 2025 | 1 |
| K233778 | Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video… | 2024 | 1 |
| K231135 | Video Ureteroscope System | 2024 | 1 |
| K260516 | BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR… | 2026 | 0 |
| K252468 | Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible… | 2025 | 0 |
| K250049 | Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope… | 2025 | 0 |
| K250785 | Single-use Flexible Ureteroscope | 2025 | 0 |
Has anything in its family been recalled? (1 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.
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 6 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 6 companies; a new generation was cleared every 2.9 years on median.
- 8 of the 24 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K221158 (Guangzhou Red Pine Medical Instrument Co., Ltd., 2023) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K131369.
How does its category compare?
All FGB devicesFGB Ureteroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · FGB
17in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGB
134in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGB
15in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGB
1,307in 2025
MAUDE reports naming product code FGB, 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 | 0 | — | 0 | 6 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 1 | — | 0 | 8 |
| 2014 | 2 | — | 0 | 12 |
| 2015 | 1 | — | 0 | 16 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 2 | — | 0 | 142 |
| 2018 | 4 | 191 | 0 | 118 |
| 2019 | 2 | — | 0 | 207 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 3 | 191 | 0 | 325 |
| 2022 | 5 | 205 | 4 | 455 |
| 2023 | 8 | 183 | 1 | 458 |
| 2024 | 16 | 217 | 15 | 572 |
| 2025 | 17 | 134 | 0 | 1,307 |
| 2026 | 9 | 140 | 1 | — |
What is it indicated for?
This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172098 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172098: Medical Video Endoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172098
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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