LiNA OperaScope with HDMI Cable and On-Board LCD - 6 Units, LiNA OperaScope Recording Module
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K193007 FDA 510(k)
- FDA Product Code
- HIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.1690 FDA 510(k)
- Regulation Number
- 884.1690 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LiNA OperaScope with HDMI Cable and On-Board LCD is a hysteroscope and associated accessories, designed for endoscopic visualization of the uterine cavity. It integrates a high-definition imaging system to enable detailed examination of the endometrium and cervical canal during gynecological procedures.
This device is supplied as a reusable hysteroscope system, including a recording module for capturing and storing procedural images. It requires sterile preparation for each use and is intended for use in clinical settings such as obstetrics and gynecology. The device holds FDA 510(k) clearance and MDR authorization, adhering to regulatory standards for Class II medical devices. The system is packaged as six units, each comprising the scope with an integrated LCD and HDMI cable for connectivity.
Frequently asked questions
What clinical procedures is the LiNA OperaScope primarily designed to support within obstetrics and gynecology?
The LiNA OperaScope is specifically designed for endoscopic visualization of the uterine cavity, enabling detailed examination of the endometrium and cervical canal. This makes it particularly useful for procedures like hysteroscopy, where high-definition imaging is required to assess the internal structure of the uterus.
Is the LiNA OperaScope system reusable or single-use, and how should it be prepared for each procedure?
The LiNA OperaScope is supplied as a reusable system, meaning it must undergo thorough sterile preparation for each use. This ensures compliance with clinical hygiene standards and minimizes infection risks during gynecological procedures.
What connectivity options does the LiNA OperaScope offer for recording and capturing procedural images?
The device includes an on-board LCD and an HDMI cable, allowing for direct connectivity to external recording systems. This enables real-time visualization and storage of high-definition images during procedures, enhancing documentation and review capabilities.
How is the LiNA OperaScope packaged, and what does each unit include?
The device is packaged as six units, with each unit consisting of the reusable hysteroscope itself, which features an integrated LCD screen and an HDMI cable for connectivity. The recording module is also included to capture and store procedural images.
What regulatory pathways has the LiNA OperaScope followed, and what does this indicate about its compliance?
The LiNA OperaScope holds both FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming it meets regulatory standards for Class II medical devices. This indicates it has undergone rigorous evaluation to ensure safety, performance, and compliance with applicable guidelines for obstetrics/gynecology use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Lina - Wikipedia
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K193007 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lina Medical ApS
Sources (2)
- FDA 510(k) K193007 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026