510(k) · Cleared
ClearedGOLNIT Non-aborbable PTFE Surgical Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Antarma, LLC Dba Golnit Sutures · NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Cleared on Sep 4, 2019 as substantially equivalent to K163049 (Antarma Dba Golnit Sutures, 2017) and 3 other predicates after a 30-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- Sep 4, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- NBY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K072076 (2007). 6 ancestors in all, the oldest K003028 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK072076 Cytoplast Ptfe SutureOsteogenics Biomedical, Inc. · 2007
- 2 generations backK140415 MonotexRiverpoint Medical · 2014
- 1 generation backK173335 Gazelle PTFE and Suture Delivery DeviceDura Tap, LLC · 2018
- This deviceK192088 GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit Sutures · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K072076 | Cytoplast Ptfe Suture | Osteogenics Biomedical, Inc. | 2007 | — |
| −2 | K140415 | Monotex | Riverpoint Medical | 2014 | — |
| −1 | K173335 | Gazelle PTFE and Suture Delivery Device | Dura Tap, LLC | 2018 | — |
| 0 (this device) | K192088 | GOLNIT Non-aborbable PTFE Surgical Suture | Antarma, LLC Dba Golnit Sutures | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2017 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K163049 | GOLNIT Non-Absorbable PTFE Surgical SutureSummary page 4…d Plastic and Reconstructive Surgery (DHT4B) III. PREDICATE DEVICE The predicate devices for this submission are Antarma’s GOLNIT Non-absorbable PTFE Surgical Suture (K163049, primary predicate device), Osteogenics Biomedical, Inc.’s Cytoplast PTFE Suture (K072076, secondary predicate device), Foosin Me… | 2017 |
| * | K072076 | Cytoplast Ptfe SutureSummary page 4…s for this submission are Antarma’s GOLNIT Non-absorbable PTFE Surgical Suture (K163049, primary predicate device), Osteogenics Biomedical, Inc.’s Cytoplast PTFE Suture (K072076, secondary predicate device), Foosin Medical Supplies Inc., Ltd’s WEGO-PTFE Suture (K170842, third predicate device) and Dura Tap… | 2007 |
| * | K170842 | Wego-PtfeSummary page 4…mary predicate device), Osteogenics Biomedical, Inc.’s Cytoplast PTFE Suture (K072076, secondary predicate device), Foosin Medical Supplies Inc., Ltd’s WEGO-PTFE Suture (K170842, third predicate device) and Dura Tap LLC’s Gazelle PTFE Suture and Delivery Device (K173335, fourth predicate device). None of t… | 2017 |
| * | K173335 | Gazelle PTFE and Suture Delivery DeviceSummary page 4…ary predicate device), Foosin Medical Supplies Inc., Ltd’s WEGO-PTFE Suture (K170842, third predicate device) and Dura Tap LLC’s Gazelle PTFE Suture and Delivery Device (K173335, fourth predicate device). None of these predicates have been the subject to a design-related recall. No reference devices were u… | 2018 |
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 12 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 6 ancestors has a recall.
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. 2019, 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 GOLNIT Non-Absorbable PTFE Surgical Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental, cardiovascular and general surgeries, as well as repair of the dura mater. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192088: GOLNIT Non-aborbable PTFE Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192088
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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