# K192278: Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)

- Pathway: 510(k) (Special)
- Applicant: Uvision360, Inc.
- Decided: Nov 1, 2019 after 71 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K921244 (1992). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190827: Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid, Uvision360, Inc. (2019) Summary page 4.

## Most influential descendants
- K210512: LUMINELLE DTx System (2021), 0 descendants of its own

## Indications for use
Hysteroscopy: The LUMINELLE DTx Hysteroscopy System is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. NOTE: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery. When LUMINELLE DTx Hysteroscopy System is specifically used with the LUMINELLE Dx 360 Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. Generally recognized indications for diagnostic hysteroscopy include: • Abnormal bleeding • Infertility and pregnancy wastage • Evaluation of abnormal hysterosalpingogram • Intrauterine foreign body • Amenorrhea • Pelvic Pain Generally recognized indications for use for operative hysteroscopy include: • Directed endometrial biopsy • Polypectomy • Submucous myomectomy • Transection of intrauterine adhesions • Transection of intrauterine septa • Endometrial ablation Cystoscopy: The LUMINELLE DTx Hysteroscopy System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures. NOTE: When LUMINELLE DTx Hysteroscopy System is specifically used with the LUMINELLE Dx 360 Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.

Source page: https://510kreport.com/device/K192278
Methodology: https://510kreport.com/methodology