Conmed Axcess Papillotome Models AX4535, AX4535FX
by Conmed Endoscopic Technologies, Inc.
510(k) K080946
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK080946 | Date20 May 2008 | 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- Withdrawn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
- KNS
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.4300
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Conmed Axcess Papillotome Models AX4535 and AX4535FX are unit, electrosurgical, endoscopic devices designed for transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or Sphincter of Oddi. This wire-guided catheter features a tapered, radiopaque tip and a triple-lumen shaft to facilitate precise cutting and manipulation during endoscopic procedures.
Used in gastroenterology and urology, these devices are supplied as reusable electrosurgical instruments. The tapered design (7F to 4.5F over the distal 5mm) and flexible distal section enable multi-directional control for accurate positioning. Sterility and regulatory compliance are ensured through FDA 510(k) clearance (K080946) under the Substantially Equivalent determination, adhering to Class II medical device standards.
Other devices from Conmed Endoscopic Technologies, Inc.
Questions
AI-generated answers, 19 Sep 2026
What medical specialties primarily use the Conmed Axcess Papillotome Models AX4535 and AX4535FX, and what procedures do they assist with?
The Conmed Axcess Papillotome Models AX4535 and AX4535FX are primarily used in gastroenterology and urology specialties. These reusable, electrosurgical devices are designed for transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or Sphincter of Oddi, facilitating precise cutting and manipulation during endoscopic procedures.
Are the Conmed Axcess Papillotome Models AX4535 and AX4535FX single-use or reusable, and how does this affect their design?
These devices are reusable electrosurgical instruments, which allows for a durable, triple-lumen shaft and tapered, radiopaque tip (7F to 4.5F over the distal 5mm) to ensure long-term precision and flexibility for multi-directional control during procedures.
What regulatory pathway was followed for FDA clearance of the Conmed Axcess Papillotome Models AX4535 and AX4535FX?
The device received FDA 510(k) clearance (K080946) under a Substantially Equivalent (SESE) determination, adhering to Class II medical device standards. The review was conducted by the Gastroenterology and Urology (GU) Advisory Committee via a traditional 510(k) process.
How does the tapered design of the Conmed Axcess Papillotome Models AX4535 and AX4535FX improve procedural accuracy?
The tapered design (7F to 4.5F over the distal 5mm) combined with a flexible distal section enables multi-directional control, allowing clinicians to achieve precise positioning during endoscopic procedures, reducing the risk of misalignment or unintended tissue damage.
What special features of the Conmed Axcess Papillotome Models AX4535 and AX4535FX make them suitable for wire-guided catheter applications?
The device features a wire-guided catheter design with a triple-lumen shaft, which enhances maneuverability and cutting precision. The radiopaque tip also improves visibility under fluoroscopy, ensuring accurate navigation during procedures targeting the Papilla of Vater or Sphincter of Oddi.