Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)
by Yuwonmeditech Co., Ltd. 510(k)
Active
510(k) K240196
Overview
The Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) is a surgical access device designed for minimally invasive procedures in gastroenterology and urology. It provides a controlled pathway through the abdominal wall without the use of a sharp blade, reducing trauma and improving safety during laparoscopic or endoscopic interventions.
This device is supplied as a sterile, single-use system comprising a sleeve (available in 5–12 mm diameters) and an obturator. It is classified under FDA product code GCJ (Laparoscope, General & Plastic Surgery) and has received FDA 510(k) clearance as substantially equivalent. Storage and handling must comply with sterile surgical instrument protocols to maintain integrity prior to use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240196 | Date18 Jun 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GCJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Questions
What types of medical procedures is the Bladeless Trocar designed to assist with, and why is it considered safer than traditional trocars?
The Bladeless Trocar is specifically designed for minimally invasive procedures in gastroenterology and urology, such as laparoscopic or endoscopic surgeries. It eliminates the need for a sharp blade, which reduces trauma to the abdominal wall and lowers the risk of complications like bleeding or tissue damage compared to traditional trocars. The controlled pathway it provides improves safety during these interventions.
Is the Bladeless Trocar reusable, or is it intended for single-use only? How should it be stored to maintain sterility?
The Bladeless Trocar is sterile and single-use only, meaning it should not be reused after a single procedure. To preserve sterility before use, it must be stored and handled according to standard sterile surgical instrument protocols, ensuring the packaging remains intact until deployment in the operating room.
What sizes are available for the Bladeless Trocar, and how does this affect its use in different procedures?
The Bladeless Trocar is available in 5–12 mm diameters, including models E05, E10, E11, E12, ES05, ES10, and ES12. The size selection depends on the specific surgical requirements—larger diameters (e.g., 10–12 mm) may accommodate broader instruments like laparoscopes, while smaller sizes (e.g., 5 mm) are ideal for delicate endoscopic procedures or reduced trauma access.
How is the Bladeless Trocar supplied, and what components does the system include?
The Bladeless Trocar is supplied as a complete sterile, single-use system consisting of two main components: a sleeve (the main access pathway) and an obturator (used to facilitate initial insertion). The obturator is removed once the sleeve is properly positioned in the abdominal wall, leaving the sleeve in place for the procedure.
What regulatory pathway did the Bladeless Trocar follow to gain market authorization, and what does this mean for clinicians?
The Bladeless Trocar received FDA 510(k) clearance under the Traditional pathway, demonstrating it is substantially equivalent to a legally marketed predicate device. This means it meets established safety and performance standards for laparoscopic/general surgery access devices (product code GCJ), ensuring clinicians can rely on its design and intended use for minimally invasive procedures in gastroenterology and urology.