Identifiers
- 510(k) Number
- K841716 FDA 510(k)
- FDA Product Code
- FBQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5090 FDA 510(k)
- Regulation Number
- 876.5090 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Endoport Erocar is a gastro-urology trocar. It is designed to function as a surgical instrument for access in gastroenterology and urology procedures.
This device is identified by FDA 510(k) number K841716 and is classified as a class 2 medical device under regulation number 876.5090. It is manufactured by Endotherapeutics.
Frequently asked questions
What is the primary purpose of the Endoport Erocar?
The Endoport Erocar is a surgical instrument specifically designed to provide access during gastroenterology and urology procedures.
What is the regulatory status of this device?
The Endoport Erocar is a class 2 medical device that has received FDA 510(k) clearance under reference number K841716, as it was found to be substantially equivalent to existing devices.
Which medical specialties is this trocar intended for?
The device is intended for use in the fields of gastroenterology and urology, as indicated by its classification under regulation number 876.5090 and its review by the relevant advisory committees.
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: ENDOPORT EROCAR 510 (k) K841716 - FDA.report, ENDOPORT EROCAR (K841716) — FDA 510 (k) | Innolitics, 510 (k) K841716 — ENDOPORT EROCAR — RegDataLab
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K841716 | Class II | Active |
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Manufacturer
- Manufacturer
- Endotherapeutics
Sources (1)
- FDA 510(k) K841716 24 fields · synced Sep 21, 2026