Endopath Dextrus Seal Cap Assembly with Accessories and Endopath Dextrus Fixed-Length Access Retractors, HAP02
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K070198 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 Dextrus Seal Cap Assembly with Accessories and Endopath Dextrus Fixed-Length Access Retractors, HAP02, is a surgical device designed for laparoscopic and minimally invasive procedures. It combines a seal cap assembly with retractors to facilitate tissue sealing and retraction, aiding in precise surgical manipulation and access within the abdominal cavity.
This device is supplied as a reusable system intended for use in operating rooms and surgical suites. It is intended for single-patient use and must be sterilized before reuse, adhering to standard medical device sterilization protocols. The retractors are fixed-length, providing controlled access during procedures, and the assembly is compatible with laparoscopic instruments. Authorized for use under FDA 510(k) clearance, it complies with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR)
Frequently asked questions
What types of surgical procedures is the Endopath Dextrus Seal Cap Assembly with Accessories intended for use in?
This device is designed specifically for laparoscopic and minimally invasive procedures within the abdominal cavity. The seal cap assembly and retractors work together to provide controlled access and tissue sealing, which is particularly useful in surgeries requiring precise manipulation and access, such as certain urological or gastrointestinal procedures.
Is the Endopath Dextrus Seal Cap Assembly reusable, and if so, how should it be prepared for reuse?
Yes, the Endopath Dextrus Seal Cap Assembly is intended for single-patient use but is reusable for multiple patients. Before reuse, it must undergo sterilization following standard medical device sterilization protocols to ensure safety and prevent cross-contamination.
What are the key features of the Endopath Dextrus Fixed-Length Access Retractors included in this assembly?
The retractors in this assembly are fixed-length, which means they provide consistent and controlled access during surgical procedures. This design helps maintain stability and precision when working within the abdominal cavity, ensuring better maneuverability for laparoscopic instruments.
How is the Endopath Dextrus Seal Cap Assembly compatible with other surgical instruments?
The assembly is designed to be compatible with standard laparoscopic instruments, allowing seamless integration into minimally invasive surgical workflows. The retractors and seal cap work together to create a stable platform for accessing and manipulating tissues during procedures.
What regulatory pathways does this device follow, and what does that mean for its use?
The Endopath Dextrus Seal Cap Assembly has been authorized under FDA 510(k) clearance, indicating it is deemed substantially equivalent to a legally marketed device. It also complies with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR), ensuring it meets stringent safety, performance, and quality standards for use in clinical settings.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K070198 | Class II | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
Sources (2)
- FDA 510(k) K070198 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026