Cysto-Gastro-Sets
by G-Flex Europe Sprl 510(k)
Active
510(k) K211909
Overview
The Cysto-Gastro-Sets are endoscopic electrosurgical devices designed for the cannulation of pancreatic pseudocysts via transgastric or transduodenal routes. These sets combine cannulation and drainage capabilities, offering an alternative to surgical or percutaneous interventions for managing pseudocysts in gastroenterology and urology procedures.
These sets are supplied as single-use, sterile devices and require an endoscope with a working channel diameter of at least 3.7 mm for the 10Fr Set, 3.2 mm for the 8.5Fr Set, or 2.8 mm for the 6Fr Set. They are intended for use with electrosurgical units operating at a recommended frequency of 80–120 watts, with caution advised against coagulation settings to prevent damage. The device is classified as Class 2 under FDA product code KNS and has received FDA 510(k) clearance (K211909) via the Traditional pathway.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK211909 | Date9 Jun 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Questions
What medical specialties are these sets primarily intended for, and how does that relate to their use in procedures?
The Cysto-Gastro-Sets are designed for use in gastroenterology and urology procedures, as indicated by their advisory committee classification. They are specifically intended for the cannulation and drainage of pancreatic pseudocysts via transgastric or transduodenal routes, offering an alternative to surgical or percutaneous interventions. This dual-specialty focus aligns with the need for minimally invasive solutions in both fields to manage pseudocyst complications.
Are these sets compatible with all endoscopes, or do they require specific working channel sizes?
Compatibility depends on the working channel diameter of the endoscope used. The Cysto-Gastro-Sets come in three sizes: 10Fr (requires ≥3.7 mm channel), 8.5Fr (requires ≥3.2 mm channel), and 6Fr (requires ≥2.8 mm channel). Always verify your endoscope’s channel size before use to ensure proper fit and functionality.
How should these sets be stored, and what precautions should be taken to maintain their sterility?
The Cysto-Gastro-Sets are single-use, sterile devices as supplied. They should be stored in their original, unopened packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Avoid contamination by keeping the packaging sealed until immediately before use, and follow manufacturer guidelines for expiration dates to ensure sterility and performance.
What electrosurgical settings are recommended for use with these sets, and why is caution advised?
These sets are designed for use with electrosurgical units operating at 80–120 watts. Caution is advised against coagulation settings because excessive heat or coagulation modes could damage the device or surrounding tissues. The manufacturer emphasizes using appropriate cutting or blending modes to minimize risk during cannulation and drainage procedures.
What regulatory pathway was followed for FDA clearance, and what does that mean for clinicians?
The Cysto-Gastro-Sets received FDA 510(k) clearance (K211909) through the Traditional pathway, meaning they were deemed substantially equivalent to a legally marketed predicate device. For clinicians, this indicates the device has undergone rigorous review for safety and effectiveness, but it does not imply approval for specific clinical indications—only that it meets regulatory standards for its intended use in pancreatic pseudocyst drainage.