Endopath Non-Bladed Obturator Trocar System (5 MM)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K011257 FDA 510(k)
- FDA Product Code
- GCJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Endopath Non-Bladed Obturator Trocar System (5 MM) is a surgical trocar designed for laparoscopic procedures, facilitating safe and controlled insertion of instruments into the abdominal cavity. It belongs to the category of laparoscopic devices used in general and plastic surgery, enabling minimally invasive access without the need for a sharp blade.
This system is intended for single-use in sterile surgical settings and is classified under product code GCJ. It is supplied as a reusable or single-use device (as per standard laparoscopic practice) and has received FDA 510(k) clearance under the traditional review pathway. The device is regulated under Class II special controls and is distributed by Ethicon Endo-Surgery, Inc.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Endopath Non-bladed Obturator Trocar System (5 Mm), ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM) by ETHICON ENDO ..., Endopath Non-bladed Obturator Trocar System (5 Mm), K011257 - Endopath Non-bladed Obturator Trocar System (5 Mm), ENDOPATH XCEL™ Trocars | J&J MedTech US - Johnson & Johnson Medical ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011257 | Class II | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, Inc.
Sources (1)
- FDA 510(k) K011257 24 fields · synced Sep 19, 2026