# K162617: NobleStitch EL

- Pathway: 510(k) (Abbreviated)
- Applicant: Nobles Medical Technologies Ii, Inc.
- Decided: Apr 6, 2017 after 198 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- 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 K113494 (2012). 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)
- K113494: Noblestitch EL Noblestitch MR Noblestitch TA, Nobles Medical Technologies Ii, Inc. (2012) Summary page 4.

## Indications for use
The NobleStitch EL is indicated for use in the placement of sutures for soft tissue approximation in cardiovascular procedures. The NobleStitch EL is not intended for blind vascular closure.

Source page: https://510kreport.com/device/K162617
Methodology: https://510kreport.com/methodology