Custom Syrigene Kits
by Syrigene Medical Technologies, Inc. 510(k)
Active
510(k) K925822
Overview
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. Custom Syrigene Kits are medical devices comprising such piston syringes, designed for the delivery of medications or fluids in clinical settings.
These kits are supplied as non-sterile, single-use devices intended for use in general hospital environments. They are regulated under FDA 510(k) clearance (K925822) with product code FMF and are not indicated for MRI safety or reuse; storage and handling should follow standard medical device practices for non-sterile single-use products.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK925822 | Date22 Apr 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- FMF
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the intended use of Custom Syrigene Kits?
Custom Syrigene Kits are intended for the delivery of medications or fluids in clinical settings, specifically designed as piston syringes with a calibrated hollow barrel and movable plunger for medical purposes in general hospital environments.
Are Custom Syrigene Kits sterile or non-sterile, and are they single-use or reusable?
Custom Syrigene Kits are supplied as non-sterile, single-use devices, meaning they are not sterilized before distribution and are intended for one-time use only, with no indication for reuse or reprocessing.
How are Custom Syrigene Kits supplied and what regulatory pathway applies?
Custom Syrigene Kits are supplied as complete kits containing piston syringes and are regulated under FDA 510(k) clearance with K number K925822 and product code FMF, indicating they were found substantially equivalent to a legally marketed device.