Identity
- Trade Name
- LUMINELLE DTx Hysteroscopy System FDA UDI
- Generic Name
- Flexible video cystoscope, reusable FDA UDI
- Device Name
- Hysteroscopy System indicated for both Hysteroscopy and Cystoscopy to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. FDA UDI
- Model / Reference
- LumDTX-A FDA UDI
- Description
- Hysteroscopy System indicated for both Hysteroscopy and Cystoscopy to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. FDA UDI
Identifiers
- Catalog Number
- 20030 FDA UDI
- Primary DI / UDI-DI
- 00853277008046 FDA UDI
- 510(k) Number
- K181909 FDA UDI
- FDA Product Code
- HIH FDA UDIFAJ FDA UDI
- GMDN Term
- Flexible video cystoscope, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 FDA UDI876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscope sheath, single-useFlexible video cystoscope, reusableFlexible fibreoptic hysteroscope
LUMINELLE DTx Hysteroscopy System by Uvision360, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible fibreoptic hysteroscope.
- OES HYSTEROFIBERSCOPE — Olympus Medical Systems Corporation · Class II
- Endosee System — CooperSurgical, Inc. · Class II
- Endosee — CooperSurgical, Inc. · Class II
- Endosee — CooperSurgical, Inc. · Class II
- Endosee System Convenience Kit — CooperSurgical, Inc.
- OES HYSTEROFIBERSCOPE — Olympus Medical Systems Corporation · Class II
- Endosee — CooperSurgical, Inc. · Class II
- Luminelle DTx Control Hub — Uvision360, Inc. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Uvision360, Inc.
Sources (1)
- FDA UDI 65af102d-0a51-4137-9e91-f854a917cffd 36 fields · synced May 30, 2026