Safe Tip Syringe
by Devon Safety Products, Inc. 510(k)
Active
510(k) K060668
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060668 | Date12 Jun 2006 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- MEG
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Safe Tip Syringe is a syringe, antistick device designed for the administration of intramuscular injections. It is substantially equivalent to a legally marketed device and aids in the prevention of accidental needle sticks by passively and automatically deploying a sheath that covers the sharp needle upon completion of the injection.
The device is supplied by Devon Safety Products, Inc. and has received FDA 510(k) clearance under K060668. It is classified as a Class II medical device under regulation number 880.5860 and product code MEG. The device is intended for use in general hospital settings.
Other devices from Devon Safety Products, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the Safe Tip Syringe used for?
The Safe Tip Syringe is designed for the administration of intramuscular injections and aids in preventing accidental needle sticks by automatically deploying a sheath that covers the sharp needle after injection.
How is the Safe Tip Syringe supplied and is it sterile?
The device is supplied by Devon Safety Products, Inc. While the data does not explicitly state sterility, as a syringe intended for intramuscular injection, it is implied to be sterile for single-use clinical application.
Is the Safe Tip Syringe reusable or single-use?
The Safe Tip Syringe is intended for single-use only, as it is designed to prevent accidental needle sticks through automatic sheath deployment after one injection, making reuse unsafe and contrary to its protective function.
What sizes or models of the Safe Tip Syringe are available?
The device data does not specify particular sizes, volumes, or model variations of the Safe Tip Syringe; only the device name and its antistick mechanism are described.
How should the Safe Tip Syringe be stored?
Storage conditions are not detailed in the provided device data; however, as a sterile medical device for hospital use, it should be stored in a clean, dry environment according to standard medical device practices.