TC Endo Port
by Transcardiac Therapeutics, Inc.
510(k) K083218
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083218 | Date6 Mar 2009 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 1 Oct 2026
The TC Endo Port is a trocar system (Product Code GCJ) designed for minimally invasive surgical procedures. It establishes a controlled entry path for endoscopic instruments in abdominal, thoracic, laparoscopic, and gynecologic surgeries. The device consists of a sterile, single-use sleeve and a plastic obturator with a dilator tip, available in sizes ranging from 5 mm to 12 mm diameter. Its classification aligns with laparoscopes for general and plastic surgery, as defined by regulatory nomenclature.
This device is supplied sterile and intended for single-use only, ensuring compliance with surgical hygiene standards. It is intended for use in controlled clinical environments, such as operating rooms or procedure suites, where minimally invasive techniques are applied. The TC Endo Port has received FDA 510(k) clearance (K083218) under the Substantially Equivalent (SESE) determination, with regulatory oversight by the Gastroenterology and Urology advisory committees. Storage and handling must adhere to manufacturer guidelines to maintain sterility and functionality.
Questions
AI-generated answers, 1 Oct 2026
What is the TC Endo Port trocar system used for?
The TC Endo Port trocar system is designed for minimally invasive surgical procedures, creating a controlled entry path for endoscopic instruments. It is suitable for abdominal, thoracic, laparoscopic, and gynecologic surgeries, allowing surgeons to access internal tissues or organs with reduced trauma compared to traditional open surgery.
How is the TC Endo Port supplied and what are its sterility and reuse guidelines?
The TC Endo Port is supplied sterile and intended for single-use only. This ensures compliance with surgical hygiene standards and minimizes the risk of infection or cross-contamination. Single-use design also eliminates the need for reprocessing, which can be time-consuming and may introduce additional risks if not performed correctly.
What sizes are available for the TC Endo Port, and how do I select the right one?
The TC Endo Port is available in sizes ranging from 5 mm to 12 mm in diameter. The appropriate size depends on the specific surgical procedure, the instruments being used, and the anatomical access point. Larger sizes (e.g., 10 mm or 12 mm) may be required for procedures involving thicker tissues or larger instruments, while smaller sizes (e.g., 5 mm) are often used for delicate or confined spaces.
Where and how should the TC Endo Port be stored to maintain sterility?
The TC Endo Port must be stored in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. The packaging should remain intact until immediately before use to preserve sterility. Follow the manufacturer’s guidelines for storage conditions, which may include specific temperature ranges or humidity levels, to ensure the device remains functional and safe for use.
Is the TC Endo Port regulated by the FDA, and what does that mean for its use?
Yes, the TC Endo Port has received FDA 510(k) clearance under the Substantially Equivalent (SESE) determination, meaning it has been evaluated and deemed comparable to a legally marketed device that served as a predicate. This clearance ensures the device meets FDA safety and performance standards for its intended use in controlled clinical environments, such as operating rooms or procedure suites.