FDA 510(k)

Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid

Numéro K : K190827 · 2019-06-06

Date de décision2019-06-06

Code produitHIH

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid is the device name listed in this FDA 510(k) record. The listed applicant is Uvision360, Inc.. It received FDA 510(k) clearance on 2019-06-06 under 510(k) number K190827. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid?

Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid is a medical device that received FDA 510(k) clearance on 2019-06-06. The listed applicant is Uvision360, Inc.. The 510(k) number is K190827.

When did Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid receive FDA 510(k) clearance?

Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid received FDA 510(k) clearance on 2019-06-06, under 510(k) number K190827.

Who is the listed applicant for Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid?

The FDA 510(k) record lists Uvision360, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid?

The FDA product code for Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid is HIH.

Essais cliniques associés

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Autres dossiers indiquant Uvision360, Inc. en tant que demandeur

K210512LUMINELLE DTx System K192278Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)K181909Luminelle DTx Hysteroscopy System

Dispositifs connexes (Code : HIH)

K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)Karl Storz SE & CO. KG K261102UNIDRIVE Select SystemKarl Storz SE & CO. KG K254294Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)Zhejiang Geyi Medical Instrument Co., Ltd.K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)Axora Medical, Inc.K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.

Source officielle

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