Top Hypodermic Syringe Piston
by Top Surgical Manufacturers Co.
510(k) K843414
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843414 | Date7 Sep 1984 | 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- Withdrawn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
- FMF
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Top Hypodermic Syringe Piston is a syringe, piston device consisting of a calibrated hollow barrel and a movable plunger, used to inject fluids into, or withdraw fluids from, the body. It has a male connector for fitting the female connector of a hypodermic single lumen needle.
The device is supplied with a product code of FMF and is classified as a class 2 device. It is used in a general hospital setting and has an FDA 510K clearance with the number K843414. The device is substantially equivalent and was cleared on September 7, 1984.
Other devices from Top Surgical Manufacturers Co.
Questions
AI-generated answers, 23 Sep 2026
What is the Top Hypodermic Syringe Piston used for?
This device is used to inject fluids into or withdraw fluids from the body. It consists of a calibrated hollow barrel and a movable plunger, designed to fit a hypodermic single lumen needle via its male connector.
How is the device supplied and what is its product code?
The device is supplied under the product code FMF. It is classified as a class 2 medical device and is intended for use in a general hospital setting.
Is the Top Hypodermic Syringe Piston sterile and single-use?
The device data does not specify sterility or single-use status. Users should refer to the manufacturer's labeling or contact Top Surgical Manufacturers Co. for details on sterilization method and reuse instructions.
What sizes and models are available?
The provided specifications do not list available sizes or models. For specific configurations, volumes, or barrel sizes, consult the manufacturer directly or request the product catalog.
How should the device be stored?
Storage requirements are not detailed in the device data. It is recommended to store the syringe in a dry, clean environment away from direct sunlight and extreme temperatures, following standard medical device handling protocols.