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FDA 510(k)

Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)

K-Number: K241532 · 2024-10-22

ApplicantShanghai SeeGen Photoelectric Technology Co., Ltd.
Decision Date2024-10-22
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) is a medical device manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-10-22 under approval number K241532. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)?

Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) is a medical device that received FDA 510(k) clearance on 2024-10-22. It is manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K241532.

When was Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) approved by the FDA?

Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) received FDA 510(k) clearance on 2024-10-22, under approval number K241532.

What company makes Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)?

Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) is manufactured by Shanghai SeeGen Photoelectric Technology Co., Ltd..

What is the FDA product code for Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)?

The FDA product code for Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) is FET.

Related Clinical Trials

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Shanghai SeeGen Photoelectric Technology Co., Ltd.

K211686Flexible Video-Choledo-Cysto-Ureteroscope System K222499Disposable Endoscope Valves Kit K222261Flexible Video-Choledochoscope System K243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) K252457Disposable Distal End Tape Hood

Related Devices (Code: FET)

K160044Image1 SPIES SystemKarl Storz Endoscopy America, Inc. K1728174K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EAOlympus Medical Systems Corp. K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. K161204ENDOCAM Flex HD Camera System 5521Richard Wolf Medical Instruments Corporation K182696Telepack X LEDKARL STORZ Endoscopy-America, Inc. K180583LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEADRichard Wolf Medical Instruments Corporation

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.

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