# K173110: Graftsite

- Pathway: 510(k) (Traditional)
- Applicant: Summit Medical, Ltd.
- Decided: May 18, 2018 after 231 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K840287 (1984). 12 ancestors in all.
No later device cites it as a predicate yet.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000722: Unipolar Needles, Pajunk GmbH (2000) Summary page 4.
- K053283: Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline Set, Pajunk GmbH (2006) Summary page 4.

## Indications for use
Assistance in the delivery of local anaesthetic after hamstring harvest during ligament reconstruction procedures

Source page: https://510kreport.com/device/K173110
Methodology: https://510kreport.com/methodology