Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Disposable trocar

Model / Reference

DO5A×150

FDA applicant

Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd

Primary DI / UDI-DI

06933258118606

Basic UDI-DI

69332581K01010103UR

510(k) Number

K190029 ↗

FDA Product Code

GCJ

EMDN Code

K01010103 Optical trocar, single-use

Device Class

Class IIa EUDAMED

Class II 510(k)

Regulation

21 CFR Part 876.1500

EU market of registration

Germany

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Disposable Linear Cutter Stapler and Staple Cartridge--Cartridge

  Class IIb

  CE/MDR

• Disposable trocar

  Class IIa

  CE/MDR

• Disposable Endoscopic Linear Cutter Stapler and Cartridge--Cartridge

  Class IIb

  CE/MDR

• Disposable Circular Stapler

  Class IIb

  CE/MDR

• Disposable Linear Cutter Stapler and Staple Cartridge

  Class IIb

  CE/MDR

• Disposable Endoscopic Linear Cutter Stapler and Cartridge---stapler

  Class IIa

  CE/MDR

See all devices from Changzhou Xin Neng Yuan Medical Stapler Co., Ltd. →

• What are the key differences between the bladeless and optical trocars in this set, and how might a surgeon choose between them?

  The bladeless trocar is designed to minimize tissue trauma by avoiding sharp edges, making it ideal for procedures where soft tissue protection is critical. In contrast, the optical trocar features a sharp pyramidal tip, which allows for precise insertion and may be preferred when direct visualization of the insertion path is needed, such as in complex anatomical areas. Surgeons typically select based on the specific surgical approach—bladeless for general safety and optical for enhanced precision and visibility.

• Are these trocars reusable, or are they strictly for single-use? What does that mean for infection control in my facility?

  These trocars are explicitly designed for single-patient use only, ensuring sterility and eliminating cross-contamination risks. This aligns with best practices for disposable medical devices, as reuse could compromise sterility and integrity. Your facility should follow standard sterile medical device protocols, including proper disposal after use and adherence to sterile packaging guidelines during storage to maintain their sterile condition.

• How should I store these trocars to ensure they remain sterile and functional until use?

  The trocars are supplied sterile, so they must be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposing them to moisture or contamination, and check expiration dates before use. Proper storage ensures the device remains sterile and ready for minimally invasive procedures without compromising performance.

• What regulatory pathways have these trocars undergone, and how does that affect their use in my practice?

  These trocars have undergone FDA 510(k) clearance under the Gastroenterology and Urology advisory committees, confirming they meet U.S. regulatory standards for safety and effectiveness. Additionally, they comply with MDR (Medical Device Regulation) requirements, ensuring global regulatory alignment. This means they can be legally used in laparoscopic procedures within their intended scope, provided your facility adheres to sterile handling and single-use protocols.

• What are the main design features of the spiral and blunt-tip trocars, and when would a surgeon prefer one over the other?

  The spiral trocar features a helical cutting edge, which helps stabilize insertion and reduce resistance during entry into dense tissues, making it suitable for firmer anatomical areas. The blunt-tip trocar, on the other hand, is designed to minimize trauma to delicate tissues, ideal for procedures requiring extra gentleness, such as those near organs or sensitive structures. Surgeons may choose the spiral trocar for stability in tougher tissues and the blunt-tip trocar for precision in sensitive areas.