Syringe Assist Irrigation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K905102 FDA 510(k)
- FDA Product Code
- OCX 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 Syringe Assist Irrigation System is an Endoscopic Irrigation/Suction System designed to facilitate irrigation during endoscopic procedures. It aids in flushing fluids through endoscopic channels to clear obstructions, improve visualization, or deliver therapeutic agents while minimizing manual effort.
This system is supplied as a single-use device, featuring a 10CC syringe with 30-inch tubing. It is intended for use in gastroenterology and urology settings, adhering to FDA 510(k) clearance (K905102) under regulatory classification OCX. No specific MRI safety or sterility details are provided beyond standard single-use medical device requirements.
Frequently asked questions
What is the Bard Syringe Assist Irrigation System used for?
This system is designed to assist with irrigation during endoscopic procedures in gastroenterology and urology. It helps flush fluids through endoscopic channels to clear obstructions, enhance visualization, or deliver therapeutic agents, minimizing the need for manual syringe handling.
How is the Bard Syringe Assist Irrigation System supplied?
The system is supplied as a single-use device, including a 10CC syringe connected to 30-inch tubing. This setup ensures sterility and convenience for one-time procedural use, reducing the risk of cross-contamination.
Is the Bard Syringe Assist Irrigation System reusable?
No, the Bard Syringe Assist Irrigation System is explicitly designed for single-use only. This design choice aligns with medical best practices to maintain sterility and patient safety during endoscopic procedures.
What are the key components of the Bard Syringe Assist Irrigation System?
The system consists of a 10CC syringe and 30-inch tubing. These components work together to facilitate controlled irrigation, ensuring effective fluid delivery through endoscopic channels without manual syringe manipulation.
What regulatory clearance does the Bard Syringe Assist Irrigation System hold?
The device holds FDA 510(k) clearance under the product code OCX, with a clearance number of K905102. This classification confirms its substantial equivalence to a predicate device and compliance with regulatory standards for endoscopic irrigation/suction systems.
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: BARD (R) SYRINGE ASSIST IRRIGATION (K905102) - Innolitics, C.R. Bard 160130 - SYSTEM, IRRIGATION, SYRINGE ASSIST, EACH, Bard 160130 Syringe Assist Irrigation System Set (X), K905102 FDA 510 (k) - BARD SYRINGE ASSIST IRRIGATION
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K905102 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K905102 24 fields · synced Oct 1, 2026