510(k) · Cleared
ClearedAesculap Novosyn Absorbable Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Dec 18, 2012 as substantially equivalent to K980704 (Aesculap, Inc., 1998) and 1 other predicate after a 103-day review. Its family tree reaches back 1 generation to 1998. 5 later devices descend from it.
- Decided
- Dec 18, 2012
- Review
- 103 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K980704 (1998). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK980704 Safil Synthetic Absorbable Surgical SutureAesculap, Inc. · 1998
- This deviceK122734 Aesculap Novosyn Absorbable SutureAesculap, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK130735 Synthetic Absorbable SutureFoosin Medical Supplies Inc., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK180027 ACCUSYTE 3D Fiducial MarkerRadiation Products, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK173043 Holycon Synthetic Absorbable SuturesNantong Holycon Medical Devices Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK170661 Novosyn Quick Absorbable SutureAesculap, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK161629 CrylrexSm Eng Co., Ltd. · 2017
Most influential descendants
Showing 5 of 5 · See all- K130735Synthetic Absorbable SutureFoosin Medical Supplies Inc., Ltd. · 2014 · cites it directly3descendants
- K180027ACCUSYTE 3D Fiducial MarkerRadiation Products, LLC · 2018 · 2 generations on0descendants
- K173043Holycon Synthetic Absorbable SuturesNantong Holycon Medical Devices Co., Ltd. · 2017 · 2 generations on0descendants
- K170661Novosyn Quick Absorbable SutureAesculap, Inc. · 2017 · cites it directly0descendants
- K161629CrylrexSm Eng Co., Ltd. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980704 | Safil Synthetic Absorbable Surgical Suture | Aesculap, Inc. | 1998 | — |
| 0 (this device) | K122734 | Aesculap Novosyn Absorbable Suture | Aesculap, Inc. | 2012 | — |
| +1 | K130735 | Synthetic Absorbable Suture | Foosin Medical Supplies Inc., Ltd. | 2014 | — |
| +2 | K180027 | ACCUSYTE 3D Fiducial Marker | Radiation Products, LLC | 2018 | — |
| +2 | K173043 | Holycon Synthetic Absorbable Sutures | Nantong Holycon Medical Devices Co., Ltd. | 2017 | — |
| +1 | K170661 | Novosyn Quick Absorbable Suture | Aesculap, Inc. | 2017 | — |
| +2 | K161629 | Crylrex | Sm Eng Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 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 GAM? 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 GAM device
- #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 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 |
|---|---|---|---|
| * | K980704 | Safil Synthetic Absorbable Surgical SutureSummary page 1…AL EOUIVALENCE Aesculap®, Inc. believes that the Novosyn Absorbable Suture issubstantially equivalent to: " Safi) Synthetic Absorbable Surgical Suture, Aesculap Inc. (K980704) * Coated Vicryl (Polyglactin 910) Suture, Ethicon Inc. (K022269) DEVICE DESCRIPTION Novosyn is a synthetic absorbable braided… | 1998 |
| * | K022269 | Coated Vicryl* (Polyglactin 910) SutureSummary page 1…Suture issubstantially equivalent to: " Safi) Synthetic Absorbable Surgical Suture, Aesculap Inc. (K980704) * Coated Vicryl (Polyglactin 910) Suture, Ethicon Inc. (K022269) DEVICE DESCRIPTION Novosyn is a synthetic absorbable braided surgical suture which is supplied sterile. Novosyn is composed of a… | 2002 |
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)
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 GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, 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 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
What is it indicated for?
Novosyn sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122734: Aesculap Novosyn Absorbable Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122734
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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