# GAP: Suture, Nonabsorbable, Silk

- Device class: 2; regulation: 21 CFR 878.5030; FDA's rule: 510(k) required
- FDA decisions: 41
- 510(k) review time 2021–2025: median 301 days (middle half 185–495)
- Recalls: 24 (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)
- 2004: 1
- 2005: 1
- 2006: 1
- 2007: 1
- 2008: 1
- 2016: 2
- 2017: 1
- 2018: 1
- 2023: 1
- 2024: 3

## Most-cited predicates
- K080684: WG-Surgical Sutures with Needle (2008), cited by 5
- K041514: Truesilk Non-Absorbable Silk Surgical Suture (2005), cited by 2
- K990089: Silkam Nonabsorbable Silk Surgical Suture (1999), cited by 2
- K012124: Mersilk Black Silk Braided Non-Absorbable Suture, Usp (2001), cited by 2
- K980124: Sofsilk Suture (1998), cited by 2
- K930825: Suture Nonabsorbable-Nylon,Silk,Polyester,Stainles (1994), cited by 2
- K172149: FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture,  FILAPROP - Non Absorbable Polypropylene surgical Suture (2017), cited by 1
- K160623: FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture (2016), cited by 1
- K930739: Sutures Polyprop., Polyetheline, Nylon & Silk (1994), cited by 1
- K982853: Silk Suture (1999), cited by 1

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