510(k) · Cleared
ClearedTissueStat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Durastat, LLC · NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Cleared on Nov 9, 2023 as substantially equivalent to K173335 (Dura Tap, LLC, 2018) after a 190-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- Nov 9, 2023
- Review
- 190 days
- Class
- Class II
- Product code
- NBY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K072076 (2007). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K173335 | Gazelle PTFE and Suture Delivery DeviceSummary page 5…; Manual Surgical Instruments for General Use, 878.4800 Regulatory Class: II Product Code: NBY III. PREDICATE DEVICE DuraStat® Gazelle PTFE Suture and Delivery Device (K173335) formerly DuraTap Gazelle PTFE Suture and Delivery Device. Reference Devices: Riverpoint Medical MonoTex ® PTFE Suture (K140415)… | 2018 |
| † | K140415 | Monotex | 2014 |
| † | K100006 | HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K173335.
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. 2023, 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?
The TissueStat PTFE (polytetrafluroethylene) Suture and Delivery Device is indicated for use in all types of soft tissue approximation and / or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater.
TissueStat PTFE Sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues.
TissueStat PTFE Sutures are provided sterile as a single use device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231277: TissueStat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231277
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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