510(k) · Cleared
ClearedPremilene Nonabsorbable Polypropylene Surgical Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Cleared on May 4, 1998 after a 70-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- May 4, 1998
- Review
- 70 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK980703 Premilene Nonabsorbable Polypropylene Surgical SutureAesculap, Inc. · 1998
- Descendant · cites it directly · 5 of its ownK133890 Aesculap Optilene Nonabsorbable SutureAesculap, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK151165 Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureAesculap, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK192420 Crownjun Nylon SutureKono Seisakusho Co., Ltd. · 2020
- Descendant · 4 generations on · 0 of its ownK221280 VessealLydus Medical, Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK212603 Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K133890Aesculap Optilene Nonabsorbable SutureAesculap, Inc. · 2014 · cites it directly5descendants
- K151165Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureAesculap, Inc. · 2016 · 2 generations on3descendants
- K192420Crownjun Nylon SutureKono Seisakusho Co., Ltd. · 2020 · 3 generations on1descendant
- K221280VessealLydus Medical, Ltd. · 2022 · 4 generations on0descendants
- K212603Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980703 | Premilene Nonabsorbable Polypropylene Surgical Suture | Aesculap, Inc. | 1998 | — |
| +1 | K133890 | Aesculap Optilene Nonabsorbable Suture | Aesculap, Inc. | 2014 | — |
| +2 | K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | Aesculap, Inc. | 2016 | — |
| +3 | K192420 | Crownjun Nylon Suture | Kono Seisakusho Co., Ltd. | 2020 | — |
| +4 | K221280 | Vesseal | Lydus Medical, Ltd. | 2022 | — |
| +3 | K212603 | Non Absorbable Surgical Nylon Suture | Shandong Haidike Medical Product Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 GAW? 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 GAW device
- #1 K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional…score 14.4 · 12 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 |
|---|---|---|---|
| * | — | Prolene® Nonabsorbable Polypropylene Surgical Suture Named without a submission number | |
| * | — | Surgilene® Nonabsorbable Polypropylene Surgical Suture Named without a submission number | |
| * | — | Sharpoint Polypropylene Surgical Suture Named without a submission number |
What descends from it? (7)
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, K133890 (Aesculap, Inc., 2014) has gone furthest, with 5 descendants of its own.
How does its category compare?
All GAW devicesGAW Suture, Nonabsorbable, Synthetic, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GAW
80in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAW
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAW
2,545in 2025
MAUDE reports naming product code GAW, 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 | 1 | — | 1 | 73 |
| 2008 | 0 | — | 0 | 75 |
| 2009 | 0 | — | 0 | 71 |
| 2010 | 2 | — | 0 | 85 |
| 2011 | 0 | — | 0 | 84 |
| 2012 | 3 | 86 | 0 | 194 |
| 2013 | 3 | 36 | 0 | 191 |
| 2014 | 2 | — | 0 | 437 |
| 2015 | 3 | 252 | 0 | 422 |
| 2016 | 1 | — | 0 | 440 |
| 2017 | 3 | 145 | 0 | 413 |
| 2018 | 3 | 80 | 0 | 685 |
| 2019 | 1 | — | 0 | 1,803 |
| 2020 | 2 | — | 0 | 1,493 |
| 2021 | 0 | — | 0 | 1,652 |
| 2022 | 2 | — | 0 | 1,563 |
| 2023 | 1 | — | 0 | 1,811 |
| 2024 | 1 | — | 0 | 2,348 |
| 2025 | 0 | — | 0 | 2,545 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
Premilene® sutures are indicated for use in all types of general soft tissue approximation and ligation, including use in cardiovascular, ophthalmic, 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/K980703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980703: Premilene Nonabsorbable Polypropylene Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980703
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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