Identifiers
- 510(k) Number
- K954864 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 Aslan Modular Instrument is a surgical device classified under product code GCJ, designed for endoscopic procedures. It is intended for grasping, manipulating, cutting, and coagulating tissue during minimally invasive surgeries, providing precise control for surgical tasks in gastrointestinal or urological applications.
This device is supplied as a reusable instrument and is regulated under FDA 510(k) clearance (K954864), granted in 1996. It is intended for use in clinical settings by qualified surgeons, with no specific mention of MRI safety or sterility requirements in the available data. The modular design supports various endoscopic applications, though exact specifications for sizing or configuration are not detailed in the provided records.
Frequently asked questions
What types of surgical procedures is the Aslan Modular Instrument primarily used for, and why is it considered modular?
The Aslan Modular Instrument is designed for endoscopic procedures in gastrointestinal or urological applications, enabling precise grasping, manipulation, cutting, and coagulation of tissue. Its modular design allows flexibility to adapt to different surgical tasks within these specialties, supporting a range of minimally invasive techniques without requiring multiple standalone tools.
Is the Aslan Modular Instrument intended for single-use or reusable applications, and how should it be maintained?
The Aslan Modular Instrument is reusable, as explicitly stated in the device description. While the data does not specify cleaning or sterilization protocols, reusable surgical instruments typically require thorough cleaning, disinfection, and sterilization between uses to ensure safety and functionality. Always follow manufacturer guidelines or clinical protocols for reprocessing.
What regulatory pathway was followed for FDA clearance of this device, and when was it approved?
The Aslan Modular Instrument received FDA 510(k) clearance under the traditional review pathway, with a decision code indicating it was determined *substantially equivalent* to a legally marketed predicate device. The clearance was granted on February 9, 1996, following submission on October 23, 1995, to the Gastroenterology/Urology (GU) advisory committee.
Does the Aslan Modular Instrument have any specific size or configuration options, and how might that affect its use?
The provided data does not detail specific sizing or configuration options for the Aslan Modular Instrument, though its modular design suggests adaptability for various endoscopic procedures. Clinicians should confirm compatibility with their intended surgical approach, as the lack of explicit dimensions may require consultation with the manufacturer or review of accompanying technical documentation for optimal 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: Aslan Medical Hospital Products, K982287 FDA 510 (k) - ASLAN SENSOR MODULAR INSTRUMENT, ASLAN SENSOR MODULAR INSTRUMENT (K982287) — FDA 510(k) | Innolitics, ASLAN MODULAR INSTRUMENT (K954864) — FDA 510 (k) | Innolitics, ASLAN SENSOR MODULAR INSTRUMENT 510(k) K982287 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K954864 | Class II | Active |
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Manufacturer
- Manufacturer
- Aslan Medical Technologies, Ltd.
Sources (1)
- FDA 510(k) K954864 24 fields · synced Sep 19, 2026