510(k) · Cleared
ClearedGazelle PTFE and Suture Delivery Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dura Tap, LLC · NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Cleared on Feb 8, 2018 as substantially equivalent to K140415 (Riverpoint Medical, 2014) after a 108-day review. Its family tree reaches back 2 generations to 2007. 2 later devices descend from it.
- Decided
- Feb 8, 2018
- Review
- 108 days
- Class
- Class II
- Product code
- NBY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K072076 (2007). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK072076 Cytoplast Ptfe SutureOsteogenics Biomedical, Inc. · 2007
- 1 generation backK140415 MonotexRiverpoint Medical · 2014
- This deviceK173335 Gazelle PTFE and Suture Delivery DeviceDura Tap, LLC · 2018
- Descendant · cites it directly · 0 of its ownK231277 TissueStatDurastat, LLC · 2023
- Descendant · cites it directly · 0 of its ownK192088 GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit Sutures · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K072076 | Cytoplast Ptfe Suture | Osteogenics Biomedical, Inc. | 2007 | — |
| −1 | K140415 | Monotex | Riverpoint Medical | 2014 | — |
| 0 (this device) | K173335 | Gazelle PTFE and Suture Delivery Device | Dura Tap, LLC | 2018 | — |
| +1 | K231277 | TissueStat | Durastat, LLC | 2023 | — |
| +1 | K192088 | GOLNIT Non-aborbable PTFE Surgical Suture | Antarma, LLC Dba Golnit Sutures | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NBY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NBY device
- #1 K231277 TissueStatscore 6.9 · 3 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K140415 | MonotexSummary page 4…oethylene, 878.5035 Common Name PTFE Nonabsorbable Surgical Sutures Product Code NBY Predicate Device Riverpoint Medical MONOTEX PTFE Suture – K140415 Special Controls FDA Guidance, “Class II Special Controls Guidance Document: Surgical Sutures, Guidanc… | 2014 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K231277 (Durastat, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K140415.
How does its category compare?
All NBY devicesNBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NBY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NBY
58in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBY
No recall names NBY since 2007.
Adverse event reports per year · NBY
1in 2025
MAUDE reports naming product code NBY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 161 | 0 | 0 |
| 2018 | 4 | 99 | 0 | 0 |
| 2019 | 3 | 58 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173335 · printed Nov 5, 2026
Cite this page
510(k) Report. “K173335: Gazelle PTFE and Suture Delivery Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K173335
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026