510(k) · Cleared
ClearedWego-Ptfe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foosin Medical Supplies Inc., Ltd. · NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Cleared on Jul 31, 2017 as substantially equivalent to K072076 (Osteogenics Biomedical, Inc., 2007) after a 132-day review. Its family tree reaches back 1 generation to 2007. 1 later device descends from it.
- Decided
- Jul 31, 2017
- Review
- 132 days
- Class
- Class II
- Product code
- NBY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K072076 (2007). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K192088GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit Sutures · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K072076 | Cytoplast Ptfe Suture | Osteogenics Biomedical, Inc. | 2007 | — |
| 0 (this device) | K170842 | Wego-Ptfe | Foosin Medical Supplies Inc., Ltd. | 2017 | — |
| +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 |
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 |
|---|---|---|---|
| * | K072076 | Cytoplast Ptfe SutureSummary page 5…Strands and the requirements of the United States Pharmacopoeia for Non-Absorbable Surgical Sutures. 5. Identification of Predicate Device 510(k) Number: K072076 Product Name: Cytoplast PTFE Suture Manufacturer: Osteogenics Biomedical, Inc.… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192088 | GOLNIT Non-aborbable PTFE Surgical Suture | 2019 | 0 |
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?
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. 2017, 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?
WEGO-PTFE is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental
and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.
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/K170842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170842: Wego-Ptfe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170842
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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