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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 the device name listed in this FDA 510(k) record. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-10-22 under 510(k) 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. The listed applicant is Shanghai SeeGen Photoelectric Technology Co., Ltd.. The 510(k) number is K241532.

When did Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) receive FDA 510(k) clearance?

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

Who is the listed applicant for Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)?

The FDA 510(k) record lists Shanghai SeeGen Photoelectric Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Shanghai SeeGen Photoelectric Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252457Disposable Distal End Tape HoodK243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)K222499Disposable Endoscope Valves KitK222261Flexible Video-Choledochoscope SystemK211686Flexible Video-Choledo-Cysto-Ureteroscope System

Related Devices (Code: FET)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee Video Processing Unit (PV-003)Proverum LimitedK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm 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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