Ultrasafe Injection System Model C200 Injector With Needle Guard

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K972877 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• Ultrasafe Model T200 Injector

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• Ultrasafe Injection System Needle Guard, Models B50, B100L, B150, B225, and B300

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See all devices from Safety Syringes, Inc. →

• What is the Ultrasafe Injection System Model C200 Injector With Needle Guard used for?

  It is designed to hold a sterile medication cartridge with needle in place while administering an injection, ensuring secure positioning during delivery of medication.

• How does the needle guard on the Ultrasafe Injection System Model C200 protect users?

  The needle guard is intended to protect the user from needle sticks after injection and during disposal of the needle cartridge unit by covering the needle following use.

• Is the Ultrasafe Injection System Model C200 Injector With Needle Guard reusable or single-use?

  The device is supplied as a single-use system, meaning it is intended for one injection procedure and should be discarded after use to prevent cross-contamination and ensure safety.

• What regulatory pathway was used for the Ultrasafe Injection System Model C200 Injector With Needle Guard?

  It received FDA 510(k) clearance under K number K972877, with a decision of substantially equivalent, and is classified as a Class II medical device.

• In what type of setting is the Ultrasafe Injection System Model C200 Injector With Needle Guard intended to be used?

  It is intended for use in general hospital settings, as indicated in the device's authorization and advisory committee classification.