# K172098: Medical Video Endoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Zhuhai Pusen Medical Technology Co., Ltd.
- Decided: Aug 31, 2017 after 51 days
- Product code: FGB (Ureteroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K931154 (1993). 24 ancestors in all.
23 later devices descend from it; 13 cite it directly.
1 of 48 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131369: Flexible Video-Uretero-Renoscope System, KARL STORZ Endoscopy-America, Inc. (2013) Summary page 5.

## Most influential descendants
- K221158: Single-Use Video Flexible Ureterorenoscope System (2023), 3 descendants of its own
- K230475: Medical Video Endoscope System (2023), 2 descendants of its own
- K230200: Single-Use Flexible Ureteroscope (2023), 2 descendants of its own
- K251951: Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F) (2025), 1 descendant of its own
- K243708: Urology Videoscope System  (Single-use Flexible Ureteroscope:  SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) (2025), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K172098
Methodology: https://510kreport.com/methodology