# K971077: Covertip Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Medisys Technologies, Inc.
- Decided: May 15, 1998 after 417 days
- Product code: MEG (Syringe, Antistick)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895024 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920321: Becton Dickinson Safety-Lok Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1992) Summary page 3.
- K895024: Punctur-Guard (TM) Blood Collection Needle, Bio-Plexus, Inc. (1990) Summary page 3.
- (no number) Standard Syringe: named in the summary without a submission number

## Indications for use
The CoverTip™ Safety Syringe is indicated for use in the administration of an intramuscular (IM) injection. The CoverTip™ Safety Syringe 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.

Source page: https://510kreport.com/device/K971077
Methodology: https://510kreport.com/methodology