Entriport

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.

Generic Name

Laparoscopic access cannula anchor, reusable

Laparoscopic access cannula, reusable

Device Name

Surgical Instruments and Accessories

Model / Ref / Catalog

G3-R12GK, G3-RM05SCN, G3-R12C, G3-RM05C

Primary DI / UDI-DI

10653405082460, 10653405082392, 10653405082446, 10653405082415

Basic UDI-DI

B-10653405082415, B-10653405082392, B-10653405082460, B-10653405082446

510(k) Number

K142464 ↗

FDA Product Code

GCJ

EMDN Code

L1207 Laparoscopic and thoracoscopic surgery cannulas, reusable

GMDN Term

Laparoscopic access cannula anchor, reusable

Laparoscopic access cannula, reusable

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 876.1500

EU market of registration

Belgium

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

Sterilization Method

Moist Heat or Steam Sterilization

Size

Length — 5 Millimeter

Width — 70 Millimeter

Length — 100 Millimeter

Width — 11 Millimeter

Width — 100 Millimeter

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• What types of surgical procedures is the Entriport Surgical Trocar System commonly used for, and why is it preferred in these settings?

  The Entriport Surgical Trocar System is primarily used in minimally invasive procedures within abdominal or pelvic cavities, such as those in general surgery, gastroenterology, and urology. It is preferred because it creates access ports with reduced trauma to surrounding tissues, enabling laparoscopic instruments to be inserted for visualization and manipulation of internal structures. Its design aligns with the needs of these specialties, where precision and minimal invasiveness are critical.

• Is the Entriport Surgical Trocar System reusable, or is it intended for single-use only? How should it be handled to maintain sterility?

  The Entriport Surgical Trocar System is explicitly intended for single-use only. To maintain sterility, it must be stored and handled according to standard sterile surgical instrument protocols. This ensures the device remains uncontaminated and intact until the time of use, as required for safe surgical procedures.

• What storage conditions should be followed for the Entriport Surgical Trocar System to ensure it remains effective and sterile?

  The Entriport Surgical Trocar System is supplied sterile, so it must be stored in a manner that preserves its sterility and integrity. This includes keeping it in its original packaging, away from direct sunlight, moisture, and extreme temperatures, and following the manufacturer’s guidelines for sterile surgical instruments to prevent contamination or damage before use.

• Are there any specific size or model variations available for the Entriport Surgical Trocar System, and how might they differ?

  The provided data does not specify exact size or model variations for the Entriport Surgical Trocar System. However, as a laparoscopic trocar system, it likely offers different diameters or lengths to accommodate varying procedural needs, such as smaller trocars for delicate procedures or larger ones for broader access. For precise sizing options, referring to the manufacturer’s product catalog or technical specifications would be necessary.

• Can the Entriport Surgical Trocar System be used in procedures involving MRI, or are there any restrictions mentioned?

  The data does not specify any MRI safety restrictions for the Entriport Surgical Trocar System, meaning it may not be explicitly labeled as MRI-safe or MRI-conditional. Clinicians should verify compatibility with their specific MRI equipment and protocols before use, as some components—even if the trocar itself is not ferromagnetic—could pose risks in an MRI environment.