# GAM: Suture, Absorbable, Synthetic, Polyglycolic Acid

- Device class: 2; regulation: 21 CFR 878.4493; FDA's rule: 510(k) required
- FDA decisions: 150
- 510(k) review time 2021–2025: median 149 days (middle half 56–318)
- Recalls: 82 (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)
- 2017: 8
- 2018: 5
- 2019: 4
- 2020: 3
- 2021: 2
- 2022: 2
- 2023: 1
- 2024: 2
- 2025: 3
- 2026: 4

## Most-cited predicates
- K944110: Vicryl Rapide Suture (1995), cited by 11
- K022269: Coated Vicryl* (Polyglactin 910) Suture (2002), cited by 11
- K984374: Surgisorb (1999), cited by 7
- K972566: Dexon Violet (1997), cited by 7
- K002639: Bioknotless Anchor (2001), cited by 6
- K072028: Quill Self-Retaining System (SRS) Comprised of Monoderm (2007), cited by 5
- K000037: Monofilament Biosyn Suture (2000), cited by 5
- K992088: Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture (1999), cited by 4
- K990951: Maxon** Sterile, Synthetic, Absorbable Suture (1999), cited by 4
- K123409: Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design (2012), cited by 4

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