CORE E3 Suction/Irrigator
510(k) K202303
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK202303 | Date19 Feb 2021 | 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- Withdrawn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
- GCJ
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Core E3 Suction/Irrigator is a single-use, battery-powered laparoscopic device designed for suction and irrigation procedures. Classified under product code GCJ, it is intended for use in general and plastic surgery, specifically within gastroenterology and urology. The device integrates a handpiece, dual tubing, and optional probes to facilitate precise fluid management during minimally invasive surgeries. Its modular design allows for interchangeable components, enhancing procedural flexibility.
This device is supplied as a sterile, single-use system and connects to standard suction apparatuses for clinical use. It operates via color-coded controls on the handpiece to regulate suction and irrigation flow. The Core E3 Suction/Irrigator is cleared under the FDA’s 510(k) pathway (K202303) as substantially equivalent to a predicate device, adhering to regulatory standards for Class 2 medical devices. Storage and handling follow standard sterile single-use protocols to maintain device integrity.
Other devices from Conmed Corporation
Questions
AI-generated answers, 1 Oct 2026
What is the Core E3 Suction/Irrigator used for?
The Core E3 Suction/Irrigator is designed for laparoscopic suction and irrigation procedures, primarily in general and plastic surgery, as well as gastroenterology and urology. Its modular handpiece, dual tubing, and optional probes enable precise fluid management during minimally invasive surgeries, improving surgical control and efficiency.
Is the Core E3 Suction/Irrigator single-use or reusable?
The Core E3 Suction/Irrigator is explicitly designed as a single-use device. This ensures sterility and reduces the risk of cross-contamination between patients, aligning with best practices for sterile medical instruments in surgical settings.
How is the Core E3 Suction/Irrigator powered and controlled?
The device is battery-powered, eliminating the need for external power sources during surgery. It features color-coded controls on the handpiece to independently regulate suction and irrigation flow, allowing clinicians to adjust fluid management dynamically during procedures.
What components does the Core E3 Suction/Irrigator include, and can they be interchanged?
The Core E3 Suction/Irrigator includes a handpiece, dual tubing, and optional probes. Its modular design permits interchangeable components, enabling clinicians to adapt the device to specific surgical requirements without compromising sterility or functionality.
How should the Core E3 Suction/Irrigator be stored to maintain integrity?
Since the Core E3 Suction/Irrigator is a sterile, single-use device, it must be stored in its original packaging until use. Proper storage conditions—protected from moisture, extreme temperatures, and physical damage—are critical to preserving sterility and device performance until deployment in a surgical setting.