510(k) · Cleared
ClearedCoaptium Connect with Tissium Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tissium SA · SFD In Situ Polymerizing Peripheral Nerve Repair Device
Cleared on Sep 8, 2025 as substantially equivalent to DEN240066 (Tissium SA, 2025) after a 75-day review. Its family tree reaches back 1 generation to 2025.
- Decided
- Sep 8, 2025
- Review
- 75 days
- Class
- Class II
- Product code
- SFD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN240066 (2025). No later device cites it as a predicate yet.
- Root · 1 generation backDEN240066 COAPTIUM Connect with TISSIUM LIGHTTissium SA · 2025
- This deviceK251957 Coaptium Connect with Tissium LightTissium SA · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN240066 | COAPTIUM Connect with TISSIUM LIGHT | Tissium SA | 2025 | — |
| 0 (this device) | K251957 | Coaptium Connect with Tissium Light | Tissium SA | 2025 | — |
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 SFD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | DEN240066 | COAPTIUM Connect with TISSIUM LIGHTSummary page 5…Connect 5.0mm (D) x 15mm (L) NCOCO6015: COAPTIUM® Connect 6.0mm (D) x 15mm (L) Predicate Device: COAPTIUM® Connect with TISSIUM® LIGHT (DEN240066 granted June 17, 2025) Device Description: COAPTIUM® Connect is a bioabsorbable coaptation system for sutureless peripheral nerv… | 2025 |
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?
- Its one ancestor has no recall.
How does its category compare?
All SFD devicesSFD In Situ Polymerizing Peripheral Nerve Repair Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SFD
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SFD
Too few SFD 510(k)s in any year since 2007 to give a median.
Recalls per year · SFD
8so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · SFD
No MAUDE report names SFD since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 8 | — |
What is it indicated for?
COAPTIUM® CONNECT with TISSIUM® LIGHT is indicated for the sutureless repair of peripheral nerve injuries not in continuity in which a gap closure ≤ 1 cm is present or can be achieved with flexion of the extremity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251957: Coaptium Connect with Tissium Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251957
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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