Sterile Dispos. Plastic Stopcocks W/Tube
by Custom Medical Devices Intl., Inc.
510(k) K800864
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK800864 | Date30 May 1980 | 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- Withdrawn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
- FMG
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The device is a sterile disposable plastic stopcock with tube, classified as a Class II medical device. It is designed for use in general hospital settings to control fluid flow in medical applications.
The device is supplied sterile and is intended for single-use. It is regulated under FDA 510(k) clearance with product code FMG and regulation number 880.5440. The device is manufactured by Custom Medical Devices Intl., Inc. and was cleared on May 30, 1980.
Other devices from Custom Medical Devices Intl., Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the purpose of the sterile disposable plastic stopcock with tube?
The device is designed for use in general hospital settings to control fluid flow in medical applications. It allows healthcare professionals to regulate the direction and volume of fluids during procedures.
Is the sterile disposable plastic stopcock with tube reusable?
No, this device is supplied sterile and is intended for single-use only. After use, it should be disposed of properly according to medical waste disposal protocols to maintain sterility and prevent cross-contamination.
What regulatory approvals does the sterile disposable plastic stopcock with tube have?
The device is regulated under FDA 510(k) clearance with product code FMG and regulation number 880.5440. It was cleared on May 30, 1980, and is classified as a Class II medical device.
How is the sterile disposable plastic stopcock with tube supplied?
The device is supplied in a sterile condition, ready for immediate use in medical procedures. It is manufactured by Custom Medical Devices Intl., Inc. and comes as a complete unit with the stopcock and attached tube.