Tahoe Suction Irrigator
510(k) K911238
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK911238 | Date27 Nov 1992 | 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- Withdrawn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
- GCX
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6740
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Tahoe Suction Irrigator is a suction irrigator valve apparatus (Product Code: GCX) designed for the simultaneous irrigation and suction of blood, bodily fluids, and debris from body cavities during surgical procedures, including laparoscopic surgery. It features a piston mechanism with a central seal and dual valve portions, housed within a valve body that integrates two inlet ports and a single outlet. The device facilitates precise fluid management by allowing controlled irrigation while simultaneously removing excess fluids, reducing contamination and improving visibility for the surgeon. Its mechanical design ensures efficient operation within sterile surgical environments.
The device is supplied as a reusable medical instrument and is intended for use in general hospital settings, as indicated by its FDA 510(k) clearance (K911238) under the General Hospital advisory committee category. It requires proper sterilization between uses and must be handled in accordance with standard surgical instrument protocols. The Tahoe Suction Irrigator is not labeled for MRI compatibility or single-use applications. Storage should follow manufacturer guidelines to maintain functionality and sterility, though specific storage conditions are not detailed in regulatory filings.
Questions
AI-generated answers, 1 Oct 2026
What is the Tahoe Suction Irrigator designed for?
The Tahoe Suction Irrigator is specifically designed for simultaneous irrigation and suction of blood, bodily fluids, and debris during surgical procedures, including laparoscopic surgery. Its piston mechanism with dual valve portions allows controlled fluid management, reducing contamination and enhancing visibility for the surgeon by removing excess fluids while delivering irrigation.
How is the Tahoe Suction Irrigator supplied and intended for use?
The device is supplied as a reusable medical instrument, intended exclusively for use in general hospital settings. It requires proper sterilization between uses to maintain sterility and functionality, adhering to standard surgical instrument protocols. Its FDA 510(k) clearance (K911238) under the General Hospital advisory committee confirms its suitability for these environments.
Is the Tahoe Suction Irrigator single-use or reusable?
The Tahoe Suction Irrigator is explicitly designed as a reusable device. It is not labeled for single-use applications, meaning it must undergo sterilization between procedures to ensure safety and effectiveness in sterile surgical environments.
What storage guidelines should be followed for the Tahoe Suction Irrigator?
While specific storage conditions are not detailed in regulatory filings, the device should be stored according to the manufacturer’s guidelines to preserve functionality and sterility. Proper handling and storage are critical to maintaining its performance in sterile surgical settings, as it is intended for repeated use.
Is the Tahoe Suction Irrigator MRI-compatible?
The device is not labeled for MRI compatibility. This means it should not be used in MRI environments, as there is no assurance of safe operation or lack of interference with MRI systems. Always verify device compatibility with imaging equipment before use.