Cleared Traditional

K233778 - Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233778 · Zhuhai Pusen Medical Technology Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
232d
Days
Class 2
Risk

K233778 is an FDA 510(k) clearance for the Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible .... Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Zhuhai Pusen Medical Technology Co., Ltd. (Zhuhai, CN). The FDA issued a Cleared decision on July 16, 2024 after a review of 232 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zhuhai Pusen Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K233778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2023
Decision Date July 16, 2024
Days to Decision 232 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 130d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FGB Ureteroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FGB Ureteroscope And Accessories, Flexible/rigid

All 112
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K233778.
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K252468 · Zhejiang Geyi Medical Instrument Co., Ltd. · Dec 2025
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K253411 · Karl Storz SE & CO. KG · Nov 2025
Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)
K250917 · Shenzhen Sanping Image Technology Co., Ltd. · Oct 2025