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

FDA 510(k) K190827 · Uvision360, Inc.

Substantially Equivalent

510(k) numberK190827

Submission

Device name
Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid
Applicant
Uvision360, Inc.
Raleigh, NC, US
Received
April 1, 2019
Decision date
June 6, 2019
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HIH – Hysteroscope (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1690
Specialty
Obstetrics/Gynecology

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More from Guangzhou Red Pine Medical Instrument Co., Ltd.

510(k)DeviceDecision
K210512LUMINELLE DTx SystemFAJ · Traditional 06/30/2021SE
K192278Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath…HIH · Special 11/01/2019SE
K181909Luminelle DTx Hysteroscopy SystemFAJ · Traditional 08/16/2018SE

Questions and answers

When was Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid cleared by the FDA?

Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid (K190827) received a 510(k) decision of Substantially Equivalent on June 6, 2019, 66 days after the submission was received.

What is the product code of K190827?

The FDA product code is HIH – Hysteroscope (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1690.