# K173335: Gazelle PTFE and Suture Delivery Device

- Pathway: 510(k) (Abbreviated)
- Applicant: Dura Tap, LLC
- Decided: Feb 8, 2018 after 108 days
- Product code: NBY (Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene)
- Device class: 2
- Regulation: 21 CFR 878.5035
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K072076 (2007). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140415: Monotex, Riverpoint Medical (2014) Summary page 4.

## Most influential descendants
- K231277: TissueStat (2023), 0 descendants of its own
- K192088: GOLNIT Non-aborbable PTFE Surgical Suture (2019), 0 descendants of its own

## Indications for use
Gazelle™ PTFE (polytetrafluroethylene) suture and Delivery Device is indicated for use in general soft tissue approximation and/or ligation, including; cardiovascular, dental, general surgical procedures and repair of the dura mater. Gazelle™PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. Gazelle™ PTFE suture and Delivery Device is provided sterile as a single use device.

Source page: https://510kreport.com/device/K173335
Methodology: https://510kreport.com/methodology