# FAM: Sigmoidoscope And Accessories, Flexible/Rigid

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 24
- 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)
- 1977: 3
- 1979: 3
- 1981: 1
- 1982: 2
- 1989: 1
- 1992: 1
- 1994: 1
- 1995: 4
- 1996: 4
- 1997: 3

## Most-cited predicates
- K932843: Flexible Video Sigmoidoscope System W/Disp. Sheath (1994), cited by 4
- K921690: Flexible Fiberoptic Sigmoidoscope System (1992), cited by 4
- K770291: Sigmoidoscope, Disposable, Model #53125 (1977), cited by 3
- K963344: Disposable SS-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic Sigmoidoscope (1996), cited by 2
- K950429: Video Sigmoidoscope (1995), cited by 1
- K792341: Pentax Flexible Sigmoidoscope Mod. FS-34 (1979), cited by 1
- K951576: FS-34P2, Fiber Sigmoidoscope (1995), cited by 1
- K951577: ES-3800, Video Sigmoidoscope (1996), cited by 1

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