# K173644: Gazelle Polypropylene Suture and Delivery Device

- Pathway: 510(k) (Abbreviated)
- Applicant: Dura Tap, LLC
- Decided: Feb 15, 2018 after 80 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: 5 generations back to K990088 (1999). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100006: HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries by Size/Need, Riverpoint Medical (2010) Summary page 5.

## Indications for use
Gazelle™ Polypropylene Suture and Delivery Device is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures. Gazelle™ Polypropylene Suture and Delivery Device is provided sterile as a single use device.

Source page: https://510kreport.com/device/K173644
Methodology: https://510kreport.com/methodology