510(k) · Cleared
ClearedSafil Synthetic Absorbable Surgical 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 May 11, 1998 after a 77-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- May 11, 1998
- Review
- 77 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK980704 Safil Synthetic Absorbable Surgical SutureAesculap, Inc. · 1998
- Descendant · cites it directly · 5 of its ownK122734 Aesculap Novosyn Absorbable SutureAesculap, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK130735 Synthetic Absorbable SutureFoosin Medical Supplies Inc., Ltd. · 2014
- Descendant · cites it directly · 3 of its ownK031286 Safil and Safil Quick Synthetic Absorbable Surgical SutureAesculap, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 1 of its ownK061796 Hepatostat Set, Model 760XVygon Corp. · 2006
- Descendant · 2 generations on · 0 of its ownK233265 Monotime and Optime RPeters Surgical · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K122734Aesculap Novosyn Absorbable SutureAesculap, Inc. · 2012 · cites it directly5descendants
- K130735Synthetic Absorbable SutureFoosin Medical Supplies Inc., Ltd. · 2014 · 2 generations on3descendants
- K031286Safil and Safil Quick Synthetic Absorbable Surgical SutureAesculap, Inc. · 2003 · cites it directly3descendants
- K061796Hepatostat Set, Model 760XVygon Corp. · 2006 · 2 generations on1descendant
- K233265Monotime and Optime RPeters Surgical · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980704 | Safil Synthetic Absorbable Surgical Suture | Aesculap, Inc. | 1998 | — |
| +1 | K122734 | Aesculap Novosyn Absorbable Suture | Aesculap, Inc. | 2012 | — |
| +2 | K130735 | Synthetic Absorbable Suture | Foosin Medical Supplies Inc., Ltd. | 2014 | — |
| +1 | K031286 | Safil and Safil Quick Synthetic Absorbable Surgical Suture | Aesculap, Inc. | 2003 | 1 |
| +2 | K061796 | Hepatostat Set, Model 760X | Vygon Corp. | 2006 | — |
| +2 | K233265 | Monotime and Optime R | Peters Surgical | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | — | DEXON® Synthetic Absorbable Surgical Suture (Davis & Geck) Named without a submission number | |
| * | — | VICRYL® Synthetic Absorbable Surgical Suture (Ethicon, Inc.) Named without a submission number | |
| * | — | POLYSORB® Synthetic Absorbable Surgical Suture (U. S. Surgical Corp.) Named without a submission number |
What descends from it? (10)
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?
- Of its descendants, K122734 (Aesculap, Inc., 2012) has gone furthest, with 5 descendants of its own.
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.
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?
Safil® sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not in cardiovascular surgery, microsurgery or 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/K980704 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980704: Safil Synthetic Absorbable Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980704
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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