FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150705 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 FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator is an access device that provides a passageway for the introduction of endoscopic instruments in general laparoscopic procedures. It is compatible with the da Vinci Si Surgical System and is designed to be used with a disposable 8.5-13mm Cannula Seal manufactured by Applied Medical.
This device is reusable and made of stainless steel. It is supplied as a complete system including both the cannula and obturator. The device has received FDA 510(k) clearance with the product code GCJ and is indicated for use in general laparoscopic procedures.
Frequently asked questions
What is the FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator used for?
It provides a passageway for introducing endoscopic instruments during general laparoscopic procedures, enabling surgical access through the abdominal wall for laparoscopic tools.
Is the FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator reusable or single-use?
The device is reusable and constructed from stainless steel, allowing for multiple uses after proper cleaning and sterilization in accordance with manufacturer guidelines.
What components are included with the FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator system?
It is supplied as a complete system containing both the 10mm endoscopic cannula and the conical blunt obturator, designed to work together as a single access unit.
What compatibility does the FloShield 10mm Endoscopic Cannula have with other devices?
It is compatible with the da Vinci Si Surgical System and designed to be used with a disposable 8.5-13mm Cannula Seal manufactured by Applied Medical for optimal sealing and instrument passage.
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: FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator ..., AccessGUDID - DEVICE: FloShield 10mm Conical Blunt Obturator ..., Floshield 10mm Endoscopic Cannula and Blunt Obturator, Floshield 10mm ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150705 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Minimally Invasive Devices, Inc.
Sources (1)
- FDA 510(k) K150705 24 fields · synced Oct 1, 2026