Guidewire, Model G-V220-3527S and Others
510(k) K072354
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK072354 | Date7 Dec 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OCY
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
This device is an Endoscopic Guidewire, classified under the Gastroenterology-Urology specialty. It is designed to assist in the navigation and placement of endoscopic instruments within the biliary, pancreatic, or urinary tracts, providing structural support and guidance during procedures such as cholangiocarcinomarectomy, stent placement, or biopsy.
The Guidewire, Models G-V220-3527S and Others, is supplied as a single-use, non-sterile device for professional medical use. It is intended for use in controlled clinical settings, such as endoscopy suites or operating rooms, and must be handled under aseptic conditions. The device is classified as Class II under FDA regulation 876.1500 and holds an FDA 510(k) clearance (K072354) with a Substantially Equivalent (SESE) determination. Multiple model variants are listed under the product code OCY and are regulated for endoscopic applications in gastroenterology and urology.
Questions
AI-generated answers, 20 Sep 2026
What medical specialties is this guidewire intended for, and how does it assist during procedures?
This endoscopic guidewire is designed for use in gastroenterology and urology procedures. It provides structural support and guidance for navigating endoscopic instruments through the biliary, pancreatic, or urinary tracts. Common applications include assisting with cholangiocarcinomarectomy, stent placement, or biopsy, ensuring precise instrument placement during these interventions.
Is this guidewire single-use or reusable, and what does that mean for handling in a clinical setting?
The guidewire is single-use only, meaning it is intended for one-time use in a controlled clinical environment like an endoscopy suite or operating room. Since it is supplied non-sterile, it must be handled under aseptic conditions before use, typically involving sterilization by the facility prior to procedure. This ensures patient safety and prevents cross-contamination.
How do I determine which model variant is right for my procedure, and are there multiple sizes available?
The device comes in multiple model variants, each listed under the product code OCY and regulated for endoscopic use in gastroenterology and urology. While the exact specifications (e.g., length, diameter, or flexibility) are not detailed here, the manufacturer offers a range of options to accommodate different procedural needs. For precise sizing, refer to the product documentation or contact Accellent, Inc. directly, as the variants are tailored for specific applications like biliary or urinary tract navigation.
What regulatory pathway was followed for this device, and what does that mean for its use in clinical practice?
This guidewire received FDA 510(k) clearance (K072354) with a Substantially Equivalent (SESE) determination, meaning it was deemed comparable to a legally marketed predicate device. It is classified as Class II under FDA regulation 876.1500, indicating it undergoes stringent review for safety and effectiveness. Clinically, this clearance confirms the device meets FDA standards for use in endoscopic procedures, but facilities should still follow local protocols and ensure proper training for staff.