HSW Laparoscope and Accessories
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K941967 FDA 510(k)
- FDA Product Code
- GCJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HSW Laparoscope and Accessories is a minimally invasive surgical device classified as an endoscope and associated accessories. It is designed to provide visual access, illumination, and manipulation within body cavities, hollow organs, and canals during laparoscopic procedures, enabling detailed observation and therapeutic interventions.
This device is intended for use in minimally invasive surgery, supplied sterile for single-use, and is regulated under FDA 510(k) clearance (K941967) and MDR compliance. It is manufactured by Henke-Sass, Wolf GmbH, with a product code GCJ, and is intended for applications in gastroenterology and urology. Storage and handling must adhere to sterile medical device protocols.
Frequently asked questions
What types of surgical procedures is the HSW Laparoscope and Accessories primarily used for, and why is it considered minimally invasive?
The HSW Laparoscope and Accessories is designed for use in minimally invasive laparoscopic procedures, particularly within the fields of gastroenterology and urology. It provides visual access, illumination, and manipulation inside body cavities, hollow organs, and canals—such as the abdomen, bladder, or gastrointestinal tract—without requiring large incisions. This reduces trauma, shortens recovery times, and minimizes complications compared to traditional open surgery.
Is the HSW Laparoscope and Accessories intended for single-use or reusable applications, and how should it be stored?
The device is sterile for single-use only, as explicitly stated in its specifications. To maintain sterility, it must be stored according to standard sterile medical device protocols, ensuring the packaging remains unopened and undamaged until use. Reuse is not recommended or supported by the manufacturer.
Does the HSW Laparoscope and Accessories come with specific accessories, and if so, what should I know about compatibility?
While the exact accessories aren’t detailed in the provided data, the device is marketed as part of a laparoscope and accessories kit, implying complementary tools like trocars, graspers, or irrigation systems. Compatibility is ensured by the manufacturer (Henke-Sass, Wolf GmbH) for laparoscopic procedures in gastroenterology and urology, but users should confirm specific accessory models and sterility status before use.
How do I verify the regulatory compliance of this device for my facility?
The HSW Laparoscope and Accessories holds FDA 510(k) clearance (K941967) and complies with MDR (Medical Device Regulation) standards. For your facility, verify compliance by checking the device’s labeling for the FDA clearance number and ensuring it matches the submitted submission (product code GCJ). Additionally, confirm that the device’s intended use aligns with your institution’s procedural protocols for gastroenterology or urology.
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: HSW endoscopes for diagnostics and therapy in Laparoscopy, HSW LAPAROSCOPE AND ACCESSORIES (K941967) — FDA 510 (k) | Innolitics, Henke-Sass, Wolf GmbH FDA 510 (k) Products (1994-2018), Hsw Laparoscope And Accessories 510 (k) FDA Premarket Notification ...
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 | K941967 | Class II | Active |
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Manufacturer
- Manufacturer
- Henke-Sass, Wolf GmbH
Sources (2)
- FDA 510(k) K941967 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026