Identifiers
- 510(k) Number
- K170867 FDA 510(k)
- FDA Product Code
- PKL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.4400 FDA 510(k)
- Regulation Number
- 876.4400 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The FTRD System Set is a Full-Thickness Resection Device for the Gastrointestinal Tract, designed for endoscopic full-thickness resection of suitable lesions and diagnostic tissue acquisition in the digestive tract. It combines hemostatic metal clips with a dedicated delivery system to facilitate precise, controlled removal of full-thickness tissue samples, including those in the stomach, duodenum, and other sections of the GI tract. This device is classified as a Hemostatic Metal Clip for the GI Tract and is intended for use in gastroenterology and urology procedures.
The FTRD System Set is supplied as a single-use, sterile, disposable device and is intended for use in endoscopic procedures. It is compatible with standard endoscopy equipment and does not contain MRI-incompatible components. The system is regulated under FDA 510(k) clearance (K170867) and falls under Device Class II (regulation number 876.4400). Storage and handling follow standard sterile medical device protocols, ensuring proper functionality and safety for clinical use.
Frequently asked questions
What is the FTRD System Set used for in clinical practice?
The FTRD System Set is designed for endoscopic full-thickness resection of suitable lesions and diagnostic tissue acquisition in the gastrointestinal (GI) tract. This includes procedures in the stomach, duodenum, and other sections of the GI tract, allowing clinicians to remove full-thickness tissue samples while maintaining hemostasis. It is particularly useful in gastroenterology and urology for accessing deeper tissue layers that conventional biopsy methods cannot reach.
How is the FTRD System Set supplied and what are its sterility and reuse specifications?
The FTRD System Set is supplied as a single-use, sterile, and disposable device. This ensures patient safety by preventing cross-contamination between procedures. Due to its single-use nature, the system cannot be reused or reprocessed, and each set must be discarded after one use in accordance with standard sterile medical device protocols.
Is the FTRD System Set compatible with standard endoscopy equipment, and does it contain MRI-incompatible components?
Yes, the FTRD System Set is designed to be compatible with standard endoscopy equipment, allowing seamless integration into existing clinical workflows. Additionally, the system does not contain any MRI-incompatible components, making it safe for use in environments where MRI scans may be required post-procedure.
What storage and handling guidelines should be followed for the FTRD System Set?
The FTRD System Set must be stored and handled according to standard sterile medical device protocols to ensure proper functionality and safety. This includes maintaining the device in its original packaging until immediately before use, protecting it from physical damage, and adhering to manufacturer-recommended storage conditions (e.g., room temperature, dry environment) to preserve sterility and performance.
What regulatory pathway does the FTRD System Set follow, and what is its classification?
The FTRD System Set is regulated under the FDA 510(k) clearance pathway, specifically with clearance number K170867. It is classified as a Device Class II under the regulation number 876.4400, which pertains to hemostatic metal clips for the GI tract. This classification reflects its intended use in endoscopic procedures requiring precise tissue removal and hemostasis.
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: Ovesco Endoscopy AG - FTRD® System, Ovesco Endoscopy AG - gastroduodenal FTRD®, Ovesco Endoscopy Gastroduodenal Full-Thickness Resection Device (FTRD®) Set, PDF Full-Thickness Resection Device for flexible endoscopy
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170867 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ovesco Endoscopy Ag
Sources (1)
- FDA 510(k) K170867 24 fields · synced Oct 1, 2026