FDA 510(k)

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

K-Nummer: K241532 · 2024-10-22

AntragstellerShanghai SeeGen Photoelectric Technology Co., Ltd.

Entscheidungsdatum2024-10-22

ProduktcodeFET

BeratungsausschussGU

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Weitere Einträge mit Shanghai SeeGen Photoelectric Technology Co., Ltd. als Antragsteller

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

Verwandte Geräte (Code: FET)

K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation K261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems Corporation K251734ProVee Video Processing Unit (PV-003)Proverum Limited K250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private Limited K250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.

Offizielle Quelle

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