510(k) · Cleared
Recalled · Class II · 2026Surgilon, Dermalon, & Ophthalon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Davis & Geck, Inc. · GAR Suture, Nonabsorbable, Synthetic, Polyamide
Cleared on Jul 13, 1998 as substantially equivalent to K930586 (Davis & Geck, Inc., 1993) after a 70-day review. Its family tree reaches back 1 generation to 1993. 27 later devices descend from it. It has been recalled 9 times.
- Decided
- Jul 13, 1998
- Review
- 70 days
- Class
- Class II
- Product code
- GAR
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 1 generation to K930586 (1993). 27 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK930586 Dermalon,Surgilon,Ophthalon,& Ophthalmic Nylon SutDavis & Geck, Inc. · 1993
- This deviceK981582 Surgilon, Dermalon, & OphthalonDavis & Geck, Inc. · 1998
- Descendant · cites it directly · 12 of its ownK110663 Pairetex Optimized Composite Mesh (Pco-FX Refrences)Sofradim Production · 2011
- Descendant · 2 generations on · 10 of its ownK131969 Symbotex (TM) Composite MeshSofradim Production · 2013
- Descendant · cites it directly · 10 of its ownK060471 FSSB Nylon Surgical SuturesFssb Chirurgische Nadeln GmbH · 2006
- Descendant · 2 generations on · 9 of its ownK080684 WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008
- Descendant · 3 generations on · 5 of its ownK142908 Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight…Sofradim Production · 2014 · Recalled
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K110663Pairetex Optimized Composite Mesh (Pco-FX Refrences)Sofradim Production · 2011 · cites it directly12descendants
- K131969Symbotex (TM) Composite MeshSofradim Production · 2013 · 2 generations on10descendants
- K060471FSSB Nylon Surgical SuturesFssb Chirurgische Nadeln GmbH · 2006 · cites it directly10descendants
- K080684WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008 · 2 generations on9descendants
- K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex…Sofradim Production · 2014 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930586 | Dermalon,Surgilon,Ophthalon,& Ophthalmic Nylon Sut | Davis & Geck, Inc. | 1993 | — |
| 0 (this device) | K981582 | Surgilon, Dermalon, & Ophthalon | Davis & Geck, Inc. | 1998 | — |
| +1 | K110663 | Pairetex Optimized Composite Mesh (Pco-FX Refrences) | Sofradim Production | 2011 | — |
| +2 | K131969 | Symbotex (TM) Composite Mesh | Sofradim Production | 2013 | — |
| +1 | K060471 | FSSB Nylon Surgical Sutures | Fssb Chirurgische Nadeln GmbH | 2006 | — |
| +2 | K080684 | WG-Surgical Sutures with Needle | Foosin Medical Supplies, Inc. | 2008 | — |
| +3 | K142908 | Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh)… | Sofradim Production | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 GAR? 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 GAR device
- #1 K261484 Tissue Approximation Systemscore 11.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K930586 | Dermalon,Surgilon,Ophthalon,& Ophthalmic Nylon SutSummary page 2…ive) to be substantially equivalent in design, composition and intended use, to the currently marketed Surgilon, Dermalon, Ophthalon non-absorbable sutures covered under K930586. C:\temp\5 1 Oksuro.doc SERVICE;. \"b“ ey, C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service w BEA… | 1993 |
What descends from it? (27)
See all 275 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 |
|---|---|---|---|---|
| Jun 24, 2026 | Class II | Z-2920-2026 | Equipment maintenance | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery. |
| Dec 21, 2023 | Class II | Z-0844-2024 | Process control | Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and… |
| Dec 2, 2022 | Class II | Z-1172-2023 | 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-1178-2023 | 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 |
| Jun 3, 2011 | Not classified | Z-2821-2011 | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product |
| Jun 3, 2011 | Not classified | Z-2820-2011 | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product |
| Jun 3, 2011 | Not classified | Z-2823-2011 | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product |
| Jun 3, 2011 | Not classified | Z-2822-2011 | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product |
| Jun 3, 2011 | Not classified | Z-2824-2011 | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GAR devicesGAR Suture, Nonabsorbable, Synthetic, Polyamide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GAR
Too few GAR 510(k)s in any year since 2007 to give a median.
Recalls per year · GAR
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAR
823in 2025
MAUDE reports naming product code GAR, 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 | 0 | — | 0 | 18 |
| 2008 | 1 | — | 1 | 14 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 39 |
| 2011 | 0 | — | 1 | 8 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 103 |
| 2015 | 1 | — | 0 | 86 |
| 2016 | 1 | — | 0 | 124 |
| 2017 | 1 | — | 0 | 180 |
| 2018 | 0 | — | 0 | 541 |
| 2019 | 0 | — | 0 | 518 |
| 2020 | 1 | — | 0 | 384 |
| 2021 | 1 | — | 0 | 532 |
| 2022 | 1 | — | 0 | 549 |
| 2023 | 1 | — | 1 | 607 |
| 2024 | 0 | — | 0 | 668 |
| 2025 | 0 | — | 0 | 823 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in Cardiovascular, Ophthalmic and Neural tissue. Surgilon (polyamide), Dermalon, Ophthalon are both braided and monofilament sutures available in white or dyed (black or blue) with a Logwood extract. These sutures are available in various lengths, diameters and quantities with or without surgical needles. These sutures are not absorbed, progressive hydrolysis of the nylon in-vivo may result in gradual loss of its tensile strength.
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/K981582 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981582: Surgilon, Dermalon, & Ophthalon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981582
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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