# GAL: Suture, Absorbable, Natural

- Device class: 2; regulation: 21 CFR 878.4830; FDA's rule: 510(k) required
- FDA decisions: 30
- Recalls: 1 (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)
- 1996: 1
- 1999: 2
- 2000: 4
- 2001: 1
- 2002: 2
- 2003: 1
- 2004: 1
- 2005: 1
- 2008: 1
- 2015: 1

## Most-cited predicates
- K930738: Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc (1994), cited by 9
- K011105: Suturtek Fastclose Fascia Closure Device (2001), cited by 4
- K994002: Plain/Chromic Catgut (2000), cited by 2
- K885018: Absorbable Surgical Gut Suture* (1989), cited by 2
- K001299: Plain and Chromic Gut Absorbable Surgical Sutures Usp (2000), cited by 2
- K991223: Absorbable Surgical Gut Suture, Plain and Chronic and Softcat Absorbable Surgical Gut Suture, Plain and Chronic (1999), cited by 2
- K030227: Suturtek Fastclose Suturing Device (2003), cited by 1
- K930589: Plain, Mild Chromic and Chromic Surgical Gut Sutur (1993), cited by 1
- K982646: Ailee Sutures and Ailee Needles (1999), cited by 1
- K993695: Liga-Loop Suture Applicator (2000), cited by 1

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