# GAN: Suture, Absorbable, Synthetic

- Device class: 2; regulation: 21 CFR 878.4830; FDA's rule: 510(k) required
- FDA decisions: 7
- 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)
- 1981: 10
- 1982: 3
- 1984: 4
- 1986: 2
- 1987: 4
- 1990: 2
- 1994: 1
- 1995: 1
- 1996: 2
- 2000: 1

## Most-cited predicates
- K960653: Monocryl (Poliglecaprone 25) Suture, Dyed (Modified) (1996), cited by 8
- K964072: Monocryl (Poliglecaprone 25) Suture, Undyed (1996), cited by 6
- K900198: Dexon II Absorbable Surgical Suture, U.S.P. (1990), cited by 3
- K003015: Ssc's PCL Monofilament Sas, Violet, Coated, Model TBD (2000), cited by 2
- K920978: Ula (Poliglecaprone 251) Synthetic Absor Sut, Dyed (1994), cited by 1

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