510(k) · Cleared
ClearedFSSB Nylon Surgical Sutures
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fssb Chirurgische Nadeln GmbH · GAR Suture, Nonabsorbable, Synthetic, Polyamide
Cleared on Jul 26, 2006 as substantially equivalent to K993998 (Trading Consultants and Distributors Intl., Inc., 2000) and 2 other predicates after a 153-day review. Its family tree reaches back 2 generations to 1993. 10 later devices descend from it.
- Decided
- Jul 26, 2006
- Review
- 153 days
- Class
- Class II
- Product code
- GAR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K930586 (1993). 4 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK930586 Dermalon,Surgilon,Ophthalon,& Ophthalmic Nylon SutDavis & Geck, Inc. · 1993
- 1 generation backK981582 Surgilon, Dermalon, & OphthalonDavis & Geck, Inc. · 1998 · Recalled
- This deviceK060471 FSSB Nylon Surgical SuturesFssb Chirurgische Nadeln GmbH · 2006
- Descendant · cites it directly · 9 of its ownK080684 WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008
- Descendant · 2 generations on · 4 of its ownK161633 Rexlon, RexsilSm Eng Co., Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK173747 RexleneSm Eng Co., Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK180701 SafePath Suturing SystemSafepath Medical, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK222944 SafePath Sulturing System-Silk Suture, SafePath Sulturing System…Safepath Medical, Inc. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K080684WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008 · cites it directly9descendants
- K161633Rexlon, RexsilSm Eng Co., Ltd. · 2017 · 2 generations on4descendants
- K173747RexleneSm Eng Co., Ltd. · 2018 · 2 generations on1descendant
- K180701SafePath Suturing SystemSafepath Medical, Inc. · 2018 · 3 generations on1descendant
- K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture…Safepath Medical, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930586 | Dermalon,Surgilon,Ophthalon,& Ophthalmic Nylon Sut | Davis & Geck, Inc. | 1993 | — |
| −1 | K981582 | Surgilon, Dermalon, & Ophthalon | Davis & Geck, Inc. | 1998 | 9 |
| 0 (this device) | K060471 | FSSB Nylon Surgical Sutures | Fssb Chirurgische Nadeln GmbH | 2006 | — |
| +1 | K080684 | WG-Surgical Sutures with Needle | Foosin Medical Supplies, Inc. | 2008 | — |
| +2 | K161633 | Rexlon, Rexsil | Sm Eng Co., Ltd. | 2017 | — |
| +2 | K173747 | Rexlene | Sm Eng Co., Ltd. | 2018 | — |
| +3 | K180701 | SafePath Suturing System | Safepath Medical, Inc. | 2018 | — |
| +3 | K222944 | SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide… | Safepath Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 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? (3)
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 |
|---|---|---|---|
| * | K993998 | NYLONSummary page 3…Dermalon® Non-absorbable Surgical Suture 510(k) Number K993998 K981582 K031531 No number yet Characteristic Intended use General soft… | 2000 |
| * | K981582 | Surgilon, Dermalon, & OphthalonSummary page 3…malon® Non-absorbable Surgical Suture 510(k) Number K993998 K981582 K031531 No number yet Characteristic Intended use General soft General soft… | 1998 |
| * | K031531 | S&T Microsurgical SutureSummary page 3…Non-absorbable Surgical Suture 510(k) Number K993998 K981582 K031531 No number yet Characteristic Intended use General soft General soft General soft tis… | 2003 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080684 | WG-Surgical Sutures with Needle | 2008 | 9 |
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 13 years and passes through 2 companies; a new generation was cleared every 8.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K080684 (Foosin Medical Supplies, Inc., 2008) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K993998.
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?
FSSB Nylon Surgical Suture (Non-absorbable Polyamide) is indicated for use in general soft tissue approximation and/or ligation including use in ophthalmic and neurological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060471 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060471: FSSB Nylon Surgical Sutures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060471
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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