GTK Veress Needles
by Guangzhou T.K Medical instrument Co., Ltd. China EUDAMED510(k)
510(k) K193339
Product code HIF
Overview
The GTK Veress Needles are classified as laparoscopic insufflators, designed for creating and maintaining pneumoperitoneum during minimally invasive surgical procedures. These needles facilitate the introduction of carbon dioxide into the abdominal cavity, enabling clear visualization and access for laparoscopic instruments in procedures such as hysterectomies or appendectomies.
These single-use, sterile devices are intended for use in obstetrics and gynecology settings. They are supplied in sterile packaging and must be handled with care to preserve sterility. The needles are regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), adhering to Class II device standards. Multiple sizes and reference codes are available, as listed in the regulatory filings, ensuring compatibility with various surgical systems.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK193339 | Date30 Jan 2020 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- HIF
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1730
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
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Questions
Are GTK Veress Needles reusable or designed for single-use only?
GTK Veress Needles are explicitly designed for single-use only. This is confirmed by the manufacturer’s description, which emphasizes they are supplied in sterile packaging and must be handled carefully to preserve sterility. Single-use devices reduce the risk of cross-contamination and ensure patient safety during laparoscopic procedures.
What surgical specialties are these needles primarily intended for?
The GTK Veress Needles are primarily intended for obstetrics and gynecology (OB/GYN) settings. This is supported by the regulatory filings, which list the medical specialty description as ‘Obstetrics/Gynecology’ and the advisory committee as ‘OB.’ They are used to create pneumoperitoneum for procedures like hysterectomies or appendectomies.
How are GTK Veress Needles packaged, and what should I consider when handling them?
GTK Veress Needles are supplied in sterile packaging to maintain sterility. Since they are single-use, it’s critical to handle them with care—avoiding contamination, rough handling, or exposure to non-sterile surfaces—to ensure they remain uncontaminated before use. Always follow manufacturer guidelines for opening and preparing the device.
What regulatory pathways have these needles undergone, and what does that mean for compliance?
The GTK Veress Needles have undergone FDA 510(k) clearance and comply with the EU Medical Device Regulation (MDR), adhering to Class II device standards. The ‘Substantially Equivalent’ decision under the FDA’s 510(k) process indicates they meet performance criteria for laparoscopic insufflators. This ensures they meet stringent safety and effectiveness requirements for use in minimally invasive surgeries.
Are there multiple sizes or models available, and how do I determine compatibility with my surgical system?
Yes, GTK Veress Needles come in multiple sizes and reference codes, as listed in the regulatory filings (e.g., FEI numbers like 1221051, 3030447506, etc.). Compatibility depends on your surgical system’s specifications—check your equipment manual or consult with your supplier to confirm the correct size or model for your procedure. The manufacturer’s variety ensures flexibility for different laparoscopic setups.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K193339
- EUDAMED