Laparoscopic Mini-Dissector/Right Angle Retractor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K914098 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)
This device is a Laparoscopic Mini-Dissector/Right Angle Retractor, classified under product code GCJ. It is designed for laparoscopic surgical procedures, combining dissection and retraction functions to facilitate precise tissue manipulation in minimally invasive abdominal or pelvic surgeries. The right-angle design allows access to confined spaces, while the mini-dissector function aids in separating tissue layers or vessels with controlled precision. Its construction is tailored for endoscopic use, ensuring compatibility with laparoscopic instruments and port systems.
The Laparoscopic Mini-Dissector/Right Angle Retractor is intended for single-use applications in sterile surgical environments. It is regulated under FDA 510(k) clearance (K914098) and falls under the Gastroenterology and Urology advisory committees. Supplied as a disposable device, it requires proper sterilization handling prior to use, adhering to standard laparoscopic instrument protocols. No specific MRI safety classification is noted, and its dimensions or additional specifications are not detailed in the regulatory submission.
Frequently asked questions
What is the Laparoscopic Mini-Dissector/Right Angle Retractor used for?
This device is designed for laparoscopic surgeries, specifically to perform two key functions: dissecting tissue layers or vessels with precision and retracting tissue at right angles. Its right-angle design allows surgeons to access confined spaces within the abdomen or pelvis, making it ideal for minimally invasive procedures where traditional retractors may not reach. The mini-dissector function ensures controlled separation of tissues, reducing the risk of unintended damage during dissection.
How is the Laparoscopic Mini-Dissector/Right Angle Retractor supplied and prepared for use?
The device is supplied as a single-use, disposable instrument, meaning it is intended for one surgical procedure only. Prior to use, it must be handled in accordance with standard sterile laparoscopic instrument protocols. This includes proper packaging integrity checks, terminal sterilization (if applicable), and adherence to aseptic techniques to ensure a sterile surgical environment. Since it is not reusable, no reprocessing or cleaning steps are required after use.
Is the Laparoscopic Mini-Dissector/Right Angle Retractor compatible with all laparoscopic instruments and port systems?
The device is specifically constructed for endoscopic use and is designed to integrate with standard laparoscopic instruments and port systems. While compatibility is implied by its classification under product code GCJ (Gastroenterology and Urology), surgeons should verify fitment with their specific port sizes and instrument setups during preoperative planning. The right-angle design may require additional consideration for spatial constraints within the surgical field.
Can the Laparoscopic Mini-Dissector/Right Angle Retractor be reused after a single surgical procedure?
No, this device is explicitly intended for single-use only. Reusing it could compromise sterility, increase infection risks, and potentially damage the instrument’s precision. Single-use disposable devices like this are engineered to maintain performance and safety for one procedure, after which they must be discarded in accordance with medical waste protocols. Reuse would violate manufacturer guidelines and regulatory expectations for laparoscopic instruments.
Are there any special storage requirements for the Laparoscopic Mini-Dissector/Right Angle Retractor?
The device should be stored in its original, unopened packaging to preserve sterility until the time of use. Storage conditions should comply with standard recommendations for laparoscopic instruments, typically in a clean, dry environment protected from moisture, extreme temperatures, and direct sunlight. If the packaging is compromised or the device is exposed to contaminants, it must be discarded and replaced with a new, sterile unit. Avoid storing it in areas prone to physical damage or pressure.
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: Laparoscopic Mini-dissector/Right Angle Retractor, Laparoscopic Mini-dissector/Right Angle Retractor, Laparoscopic Mini-dissector/Right Angle Retractor - Beudamed, Surgical Innovations Corp. · DeviceClearance, Right Angled Dissector - Integra Life
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K914098 | Class II | Active |
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Manufacturer
- Manufacturer
- Surgical Innovations Corp.
Sources (1)
- FDA 510(k) K914098 24 fields · synced Oct 5, 2026