Trocar
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by WickiMed (HuiZhou) Medical Equipment Manufacturing Co., Ltd
Identity
- Trade Name
- Trocar EUDAMED
- Device Name
- Sterile single use laparoscopic trocar EUDAMED
- Model / Reference
- WST010507C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970739457403 EUDAMED
- Basic UDI-DI
- 697073945TD006JW EUDAMED
- Direct Marketing DI
- 06970739457403 EUDAMED
- 510(k) Number
- K172038 FDA 510(k)
- FDA Product Code
- GCJ FDA 510(k)
- EMDN Code
- K01010101 TROCAR STANDARD, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
This device is a Trocar (GCJ), a surgical instrument used to create a pathway into body cavities for minimally invasive procedures. It facilitates access for laparoscopic instruments, allowing for diagnostic or therapeutic interventions in gastroenterology and urology applications without the need for a sharp blade, reducing tissue trauma.
The Auto-Locking Trocar, Bladeless Trocar, and Visible Trocar are supplied sterile for single-use and comply with FDA 510(k) clearance (K172038) and MDR requirements. Available in standard sizes, these devices are designed for use in controlled surgical environments, ensuring compatibility with MRI-safe equipment where applicable. Storage instructions and regulatory compliance details are specified in the manufacturer’s documentation.
Frequently asked questions
What types of trocars does WickiMed offer, and how do they differ from traditional trocars?
WickiMed provides three specialized trocar variants: the Auto-Locking Trocar, Bladeless Trocar, and Visible Trocar. These designs eliminate the need for a sharp blade, reducing tissue trauma during minimally invasive procedures. The Bladeless Trocar avoids cutting instruments entirely, while the Auto-Locking and Visible Trocars likely offer enhanced stability and visibility during insertion, respectively. All are intended for use in laparoscopic surgeries within gastroenterology and urology, ensuring compatibility with MRI-safe equipment where applicable.
Are these trocars reusable, or are they meant for single-use only?
The trocars from WickiMed are explicitly supplied sterile for single-use only. This design choice aligns with modern surgical best practices to minimize infection risks and ensure consistent performance. The manufacturer’s documentation emphasizes their intended use in controlled surgical environments, reinforcing the single-use recommendation.
What sizes are available for these trocars, and how do I know which one to choose?
The trocars are available in standard sizes, though exact dimensions are not specified in the provided data. Selection should be based on the specific surgical procedure and patient anatomy, typically guided by the surgeon’s preference and the requirements of the laparoscopic instruments being used. For precise sizing, refer to the manufacturer’s documentation or consult with a surgical specialist to ensure compatibility with the intended procedure.
How should these trocars be stored to maintain their sterility and functionality?
Storage instructions are detailed in the manufacturer’s documentation provided by WickiMed. Since these trocars are sterile single-use devices, they must be stored in a clean, dry environment protected from contamination until use. Proper packaging (e.g., sealed sterile pouches) should be preserved to maintain sterility. Avoid exposure to extreme temperatures or moisture, as these could compromise the device’s integrity or sterility.
What regulatory pathways have these trocars undergone, and how does that affect their use?
The trocars have undergone FDA 510(k) clearance (K172038) and comply with MDR (Medical Device Regulation) requirements, indicating they meet stringent safety and performance standards. The clearance was granted under the Gastroenterology and Urology advisory committees, confirming their intended use in minimally invasive procedures for these specialties. Clinicians should ensure the device is used within its approved indications and follow the manufacturer’s instructions to maintain compliance with regulatory standards.
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: Rong Jia Medical Co., Ltd. - wickimed.com, Wickimed (Huizhou) Equipment Trocar - allmed.wiki, PDF October 27, 2017 WickiMed (Huizhou) Medical Equipment Manufacturing Co ...
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 | K172038 | Class II | Active |
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Manufacturer
- FDA Applicant
- Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd
Sources (2)
- FDA 510(k) K172038 24 fields · synced Oct 6, 2026
- EUDAMED 5f73073e-d3f3-479a-82e2-6bb60c3aea24 61 fields · synced Jul 25, 2026