# K020500: Univec Bifurcated Sliding Sheath Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Univec, Inc.
- Decided: Mar 19, 2002 after 33 days
- Product code: SCL (Allergen And Vaccine Delivery Needles)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Univec Bifurcated Sliding Sheath Syringe is a safety version of a bifurcated needle attached to a syringe barrel with the Univec Sliding Sheath Syringe mechanism. The Univec Sliding Sheath mechanism is used to aid in the prevention of needle stick injuries. This device is used in the same manner as a standard - Bifurcated Needle to deliver vaccine or allergen to the patient.

Source page: https://510kreport.com/device/K020500
Methodology: https://510kreport.com/methodology