# K972705: Resheather Device-Metal or Plastic, Resheater/ Needle Holder Device-Plastic

- Pathway: 510(k) (Traditional)
- Applicant: Sage Products, Inc.
- Decided: Apr 30, 1998 after 283 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- 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. The FDA summary names its predicate without a number.
- (no number) NeedleGard IT™: named in the summary without a submission number
- (no number) On-Gard Systems® Recapper: named in the summary without a submission number

## Indications for use
The plastic and metal resheathers are placed at or near the point of use and allow one handed needle resheathing. The plastic and foam resheather/needle holder is placed at or near the point of use and allows one handed needle resheathing or allows the user to place the needle into the foam to temporarily hold it prior to disposal.

Source page: https://510kreport.com/device/K972705
Methodology: https://510kreport.com/methodology