Trexon Monofilament Synthetic Absorbable Suture— 510(k) K253530
Substantially EquivalentMedtronic
FDA 510(k) clearance K253530 for Trexon Monofilament Synthetic Absorbable Suture, Substantially Equivalent on 2026-05-28. Applicant: Medtronic. Device class: 2.
Summary
Medtronic's Trexon Monofilament Synthetic Absorbable Suture is filed under GAM, synthetic absorbable polyglycolic acid sutures.
Class II, 21 CFR 878.4493. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).
Medtronic filed from North Haven, Connecticut. The decision came 196 calendar days after receipt (November 13, 2025 to May 28, 2026).
Clearance details
- Applicant
- Medtronic
- Product code
- Product code GAM
- Device class
- Class 2
- Regulation
- 21 CFR 878.4493
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Haven, CT, US
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- K253620 — TroClose 1200
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Adverse events under product code GAM
product code GAM- Death
- 45
- Injury
- 5,711
- Malfunction
- 30,744
- Other
- 4
- Total
- 36,504
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.