# NBY: Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

- Device class: 2; regulation: 21 CFR 878.5035; FDA's rule: 510(k) required
- FDA decisions: 17
- 510(k) review time 2021–2025: median 190 days (middle half 190–190)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2000: 1
- 2007: 1
- 2013: 1
- 2014: 2
- 2016: 1
- 2017: 3
- 2018: 4
- 2019: 3
- 2023: 1

## Most-cited predicates
- K072076: Cytoplast Ptfe Suture (2007), cited by 7
- K140415: Monotex (2014), cited by 4
- K123811: Stitchkit (2013), cited by 3
- K160744: LOOK PTFE Suture (2016), cited by 2
- K173335: Gazelle PTFE and Suture Delivery Device (2018), cited by 2
- K163049: GOLNIT Non-Absorbable PTFE Surgical Suture (2017), cited by 1
- K003028: Cytoplast Suture; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC (2000), cited by 1
- K170842: Wego-Ptfe (2017), cited by 1

Source page: https://510kreport.com/product-code/NBY
Data by year (CSV): https://510kreport.com/product-code/NBY.csv