# K233778: Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)

- Pathway: 510(k) (Traditional)
- Applicant: Zhuhai Pusen Medical Technology Co., Ltd.
- Decided: Jul 16, 2024 after 232 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: 9 generations back to K931154 (1993). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 27 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172098: Medical Video Endoscope System, Zhuhai Pusen Medical Technology Co., Ltd. (2017) Summary page 5.

## Most influential descendants
- K252929: Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) (2026), 0 descendants 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. This instrument is also used as a suction catheter that establishes a conduit used for irrigation and aspiration of kidney stones and stone dust during ureteral lithotripsy.

Source page: https://510kreport.com/device/K233778
Methodology: https://510kreport.com/methodology