HyperSuture All Green Extension Line— 510(k) K254275
Substantially EquivalentThreadstone, LLC
FDA 510(k) clearance K254275 for HyperSuture All Green Extension Line, Substantially Equivalent on 2026-03-23. Applicant: Threadstone, LLC. Device class: 2.
Summary
Threadstone's HyperSuture All Green Extension Line is filed under GAT, nonabsorbable synthetic polyethylene sutures. The record doesn't list sizes or lengths.
Class II, 21 CFR 878.5000. It was a Traditional 510(k), and General and Plastic Surgery is both the classification panel and the review panel.
Threadstone filed from Millersville, Maryland. The decision came 83 calendar days after FDA received it (December 30, 2025 to March 23, 2026).
Clearance details
- Applicant
- Threadstone, LLC
- Product code
- Product code GAT
- Device class
- Class 2
- Regulation
- 21 CFR 878.5000
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Millersville, MD, US
Recent devices under product code GAT
view allMore clearances from Threadstone, LLC
view allAdverse events under product code GAT
product code GAT- Death
- 19
- Injury
- 4,163
- Malfunction
- 8,646
- Other
- 2
- Total
- 12,830
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.