Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

F88 URE-SD/RD Flexible Ureteroscope

K-Number: K243894 · 2025-05-02

ApplicantSg Endoscopy Pte, Ltd.
Decision Date2025-05-02
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

F88 URE-SD/RD Flexible Ureteroscope is a medical device manufactured by Sg Endoscopy Pte, Ltd.. It received FDA 510(k) clearance on 2025-05-02 under approval number K243894. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F88 URE-SD/RD Flexible Ureteroscope?

F88 URE-SD/RD Flexible Ureteroscope is a medical device that received FDA 510(k) clearance on 2025-05-02. It is manufactured by Sg Endoscopy Pte, Ltd.. The 510(k) number is K243894.

When was F88 URE-SD/RD Flexible Ureteroscope approved by the FDA?

F88 URE-SD/RD Flexible Ureteroscope received FDA 510(k) clearance on 2025-05-02, under approval number K243894.

What company makes F88 URE-SD/RD Flexible Ureteroscope?

F88 URE-SD/RD Flexible Ureteroscope is manufactured by Sg Endoscopy Pte, Ltd..

What is the FDA product code for F88 URE-SD/RD Flexible Ureteroscope?

The FDA product code for F88 URE-SD/RD Flexible Ureteroscope is FGB.

Related Clinical Trials

NCT07296835 Surgical Outcomes and Costs in Using the Shenzhen HugeMed 6.3 French Flexible Ureteroscope RECRUITING NCT07514351 FANS vs CVAC for Medium to Large Stones NOT_YET_RECRUITING

Related Devices (Code: FGB)

K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. K171076Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. K181977WiScope Digital Endoscope SystemOTU Medical, Inc. K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. K172246OLYMPUS URF-V2/V2ROlympus Medical Systems Corp. K172298OLYMPUS URF-P6/P6ROlympus Medical Systems Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑