Fisso Holding System
by Baitella AG Switzerland 510(k)
510(k) K070509 Product code GCJ
Overview
The Fisso Holding System is a mechanical device classified as a gastroenterology/urology accessory (Product Code GCJ), designed to secure and stabilize endoscopic instruments or tools during procedures. Its articulated arms and central locking mechanism provide adjustable positioning and firm retention, reducing operator fatigue and improving precision in controlled environments.
This system is supplied as a reusable medical device, intended for use in clinical settings such as endoscopy suites or operating rooms. It requires no sterility packaging and is regulated under FDA 510(k) clearance (K070509), with a decision classification of Substantially Equivalent (SESE). The device is manufactured by Baitella AG and distributed globally, adhering to regulatory standards for medical instrumentation.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK070509 | Date22 Mar 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GCJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Baitella AG
Questions
What is the Fisso Holding System primarily used for in clinical settings?
The Fisso Holding System is designed to secure and stabilize endoscopic instruments or tools during procedures like endoscopy or surgery. Its articulated arms and central locking mechanism allow adjustable positioning, reducing operator fatigue and enhancing precision by keeping tools firmly in place.
Is the Fisso Holding System single-use or reusable, and what does that mean for maintenance?
The Fisso Holding System is a reusable medical device, meaning it is intended for repeated use across multiple procedures. Since it is not sterile-packaged, it must be thoroughly cleaned, disinfected, and maintained according to standard medical device reprocessing protocols after each use to ensure safety and functionality.
How is the Fisso Holding System regulated, and what does that mean for purchasing or using it?
The Fisso Holding System is regulated under the FDA’s 510(k) clearance process (K070509) and is classified as substantially equivalent (SESE) to a predicate device. This means it has been reviewed and deemed comparable to existing devices in its category (gastroenterology/urology accessory, Product Code GCJ), ensuring it meets regulatory standards for safety and performance before clinical use.
What types of clinical environments is the Fisso Holding System intended for?
The Fisso Holding System is specifically designed for controlled clinical environments like endoscopy suites or operating rooms, where precise instrument stabilization is required during procedures involving endoscopic tools or related instruments.
Who is the manufacturer and distributor of the Fisso Holding System, and how can I contact them?
The Fisso Holding System is manufactured by Baitella AG, a company based in Amsterdam, Netherlands. For inquiries, you can contact their representative, Angelika Scherp, through the provided address or contact details: Amstel 320-I, 1017AP Amsterdam, NL.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K070509