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.
Clearance details
- Applicant
- Medtronic
- Product code
- 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
Recent devices under product code GAM
view all- K253394 — Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture
- K253852 — MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
- K252743 — STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
- K253620 — TroClose 1200
- K252820 — PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso) +1 more
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- K223178 — SelectSite C304 Deflectable Catheter System, C315 Delivery System
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.