Aslan Dual Action Jaws Grasping Forceps
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K944082 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 Dual Action Jaws Grasping Forceps is a grasping instrument designed for medical procedures. It features dual action jaws that provide enhanced control during grasping operations.
This device is supplied by Aslan Medical Technologies, Ltd. and is authorized under FDA 510(k) clearance K944082 with product code GCJ. The device is intended for use in gastroenterology and urology procedures, though specific sterility, single-use or reusable status, MRI safety, and storage details are not provided in the available data.
Frequently asked questions
What clinical specialties is this forceps intended for?
The device is intended for use in gastroenterology and urology procedures, as indicated by the advisory committee description and the product’s design for grasping tasks in those fields.
Is the ASLAN Dual Action Jaws Grasping Forceps a single‑use or reusable instrument?
The available data do not specify sterility or single‑use versus reusable status, so users must refer to the manufacturer’s labeling or instructions for use to determine the appropriate handling and reprocessing protocol.
What regulatory clearance does this forceps have?
The forceps received traditional FDA 510(k) clearance (K944082) with a decision of substantially equivalent, meaning it was found comparable to a legally marketed predicate device.
How are the jaws designed to improve performance?
The instrument features dual‑action jaws, which allow the clinician to apply controlled, simultaneous pressure from both sides of the tip, enhancing grip stability and precision during tissue manipulation.
What information is missing that I should verify before purchase?
Key details such as sterility level, whether the device is intended for single‑use or multiple‑use, MRI safety, and storage requirements are not provided in the data and should be confirmed with Aslan Medical Technologies before clinical 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 DUAL ACTION JAWS GRASPING FORCEPS (K944082) — FDA 510 (k ..., ASLAN DUAL ACTION JAWS GRASPING FORCEPS 510(k) K944082 - fda.report, 510(k) K944082 — ASLAN DUAL ACTION JAWS GRASPING FORCEPS, Aslan Dual Action Jaws Grasping Forceps - allmed.wiki, Aslan Medical Technologies, Ltd. · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K944082 | Class II | Active |
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Manufacturer
- Manufacturer
- Aslan Medical Technologies, Ltd.
Sources (1)
- FDA 510(k) K944082 24 fields · synced Sep 27, 2026