# K961049: Flex Needle

- Pathway: 510(k) (Traditional)
- Applicant: Lighthouse Medical, Inc.
- Decided: Sep 18, 1996 after 187 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
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) Luther Medical Products L-CATH for Ports: named in the summary without a submission number
- (no number) Medex SureCath Port Access Catheter: named in the summary without a submission number
- (no number) SIMS Deltec Gripper: named in the summary without a submission number

## Indications for use
The FlexNeedle™ allows transcutaneous cannulation of subdermally implanted venous access ports.

Source page: https://510kreport.com/device/K961049
Methodology: https://510kreport.com/methodology