# K101180: Gripper Micro Blunt Cannula, Non-Coring Safety Needle (Gripper Micro Needle) Model: 21-3253-24, 21-3258-24, 21-3262-24,

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical MD, Inc.
- Decided: Aug 3, 2010 after 98 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 K072059 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072059: Gripper Micro Needle, Smiths Medical MD, Inc. (2007) Summary page 2.

## Indications for use
This product is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against accidental needlestick injuries.

Source page: https://510kreport.com/device/K101180
Methodology: https://510kreport.com/methodology