510(k) · Cleared
ClearedSILK Surgical Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · GAP Suture, Nonabsorbable, Silk
Cleared on Nov 23, 2016 as substantially equivalent to K153076 (Teleflexmedical, Inc., 2016) after an 89-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Nov 23, 2016
- Review
- 89 days
- Class
- Class II
- Product code
- GAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930738 (1994). 5 ancestors in all, the oldest K802093 (1980). No later device cites it as a predicate yet.
- Root · 3 generations backK930738 Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 1994 · Recalled
- 2 generations backK021019 Cottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp. · 2002 · Recalled
- 1 generation backK153076 silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II…Teleflexmedical, Inc. · 2016
- This deviceK162396 SILK Surgical SutureTeleflexmedical, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc | Deknatel, Inc. | 1994 | 9 |
| −2 | K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester Suture | Genzyme Corp. | 2002 | 7 |
| −1 | K153076 | silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX… | Teleflexmedical, Inc. | 2016 | — |
| 0 (this device) | K162396 | SILK Surgical Suture | Teleflexmedical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 2000 | 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 GAP? 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 GAP device
- #1 K222944 SafePath Sulturing System-Silk Suture…score 9.7 · 6 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 |
|---|---|---|---|
| * | K153076 | silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX…Summary page 4…ure Regulatory Class II Product Code GAP Regulation 878.5030 III. PREDICATE DEVICE Deknatel® Nonabsorbable Surgical Sutures, K153076 IV. DEVICE DESCRIPTION Deknatel Silk Suture is a nonabsorbable, sterile, surgical suture composed of an organic protein ca… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- 3 of the 5 ancestors have a recall of any class.
- 2 other devices also cite its predicate K153076.
How does its category compare?
All GAP devicesGAP Suture, Nonabsorbable, Silk: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GAP
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GAP
193in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAP
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAP
478in 2025
MAUDE reports naming product code GAP, 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 | — | 0 | 7 |
| 2008 | 1 | — | 0 | 21 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 21 | 6 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 1 | 15 |
| 2015 | 0 | — | 0 | 25 |
| 2016 | 2 | — | 0 | 54 |
| 2017 | 1 | — | 0 | 55 |
| 2018 | 1 | — | 1 | 340 |
| 2019 | 0 | — | 0 | 333 |
| 2020 | 0 | — | 0 | 426 |
| 2021 | 0 | — | 0 | 437 |
| 2022 | 0 | — | 0 | 419 |
| 2023 | 1 | — | 1 | 404 |
| 2024 | 3 | 193 | 0 | 455 |
| 2025 | 0 | — | 0 | 478 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Deknatel® Silk Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162396: SILK 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/K162396
Report an extraction error
Are you the manufacturer?
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