510(k) · Cleared
Recalled · Class II · 2022Novafil** and Vascufil** Sterile Synthetic Non-Absorbable Sutures
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Apr 1, 1999 after a 10-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 1, 1999
- Review
- 10 days
- Class
- Class II
- Product code
- GAT
- Recalls
- 2
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK990952 Novafil** and Vascufil** Sterile Synthetic Non-Absorbable SuturesUnited States Surgical, A Division of Tyco Healthc · 1999
- Descendant · cites it directly · 3 of its ownK103052 V-Loc (TM) Nonabsorbable Wound Closure DeviceCovidien, LLC · 2010
- Descendant · 2 generations on · 1 of its ownK211792 StitchKitOrigami Surgical Inc . · 2021
- Descendant · 3 generations on · 0 of its ownK221527 StitchKitOrigami Surgical Inc . · 2023
- Descendant · 2 generations on · 0 of its ownK111442 V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK013990 Lifestitch Suturing DeviceEdwards Lifesciences, LLC · 2002
Most influential descendants
Showing 5 of 5 · See all- K103052V-Loc (TM) Nonabsorbable Wound Closure DeviceCovidien, LLC · 2010 · cites it directly3descendants
- K211792StitchKitOrigami Surgical Inc . · 2021 · 2 generations on1descendant
- K221527StitchKitOrigami Surgical Inc . · 2023 · 3 generations on0descendants
- K111442V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo Stitch (TM)…Covidien, Formerly US Surgical A Divison of Tyco H · 2011 · 2 generations on0descendants
- K013990Lifestitch Suturing DeviceEdwards Lifesciences, LLC · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990952 | Novafil** and Vascufil** Sterile Synthetic Non-Absorbable Sutures | United States Surgical, A Division of Tyco Healthc | 1999 | — |
| +1 | K103052 | V-Loc (TM) Nonabsorbable Wound Closure Device | Covidien, LLC | 2010 | — |
| +2 | K211792 | StitchKit | Origami Surgical Inc . | 2021 | — |
| +3 | K221527 | StitchKit | Origami Surgical Inc . | 2023 | — |
| +2 | K111442 | V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo Stitch (TM)… | Covidien, Formerly US Surgical A Divison of Tyco H | 2011 | 2 |
| +1 | K013990 | Lifestitch Suturing Device | Edwards Lifesciences, LLC | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2021 | 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 GAT? 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 GAT device
- #1 K230311 HyperSuturescore 20.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Novafil** Named without a submission number | |
| * | — | Vascufil** Named without a submission number |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 2, 2022 | Class II | Z-1181-2023 | Packaging process control | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| Dec 2, 2022 | Class II | Z-1175-2023 | Packaging process control | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K103052 (Covidien, LLC, 2010) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAT
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAT
2,956in 2025
MAUDE reports naming product code GAT, 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 | 6 | 40 | 1 | 15 |
| 2008 | 4 | 93 | 0 | 15 |
| 2009 | 9 | 57 | 0 | 55 |
| 2010 | 11 | 27 | 3 | 79 |
| 2011 | 1 | — | 1 | 97 |
| 2012 | 6 | 61 | 0 | 253 |
| 2013 | 4 | 123 | 0 | 210 |
| 2014 | 4 | 45 | 0 | 165 |
| 2015 | 7 | 125 | 0 | 626 |
| 2016 | 10 | 139 | 0 | 688 |
| 2017 | 6 | 57 | 0 | 1,104 |
| 2018 | 6 | 95 | 0 | 1,453 |
| 2019 | 4 | 79 | 0 | 1,251 |
| 2020 | 5 | 201 | 0 | 1,220 |
| 2021 | 4 | 92 | 0 | 1,643 |
| 2022 | 5 | 109 | 0 | 1,419 |
| 2023 | 8 | 220 | 0 | 2,038 |
| 2024 | 3 | 140 | 0 | 2,597 |
| 2025 | 5 | 30 | 0 | 2,956 |
| 2026 | 5 | 83 | 0 | — |
What is it indicated for?
Novafil** and Vascufil** sutures are indicated for use as non-absorbable sutures in general and soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic surgery, but not in microsurgery and 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/K990952 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990952: Novafil** and Vascufil** Sterile Synthetic Non-Absorbable Sutures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990952
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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