# Threadstone, LLC

- Location (FDA's records): Millersville, MD
- FDA decisions: 5 (2023–2026): 5 510(k) clearances
- Product codes: GAT (5)
- 510(k) review time since 2016: median 140 days, against 140 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 6 (5 its own); citations of its devices by later devices: 5 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Teleflex Medical: 1 (https://510kreport.com/company/teleflex-medical)

## Its most-cited devices
- K230311: HyperSuture (2023), cited by 4
- K242201: HyperSuture White/Green Extension Line (2025), cited by 1

## Recent decisions
- K254275: HyperSuture All Green Extension Line (Mar 23, 2026)
- K242201: HyperSuture White/Green Extension Line (Mar 27, 2025)
- K241376: HyperSuture All Blue Extension Line (Aug 9, 2024)
- K234079: HyperSuture Extension Line (May 10, 2024)
- K230311: HyperSuture (Nov 24, 2023)

Source page: https://510kreport.com/company/threadstone