# K964131: Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: Akos Biomedical, Inc.
- Decided: Jun 27, 1997 after 255 days
- Product code: FAM (Sigmoidoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K792341 (1979). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853585: Olympus Evs-Endoscopic Video Image & Data Sys, Olympus Corp. (1986) Summary page 1.
- K951576: FS-34P2, Fiber Sigmoidoscope, Pentax Precision Instrument Corp. (1995) Summary page 1.
- K951577: ES-3800, Video Sigmoidoscope, Pentax Precision Instrument Corp. (1996) Summary page 1.
- K951579: EC-3800TL, Video Colonoscope, Pentax Precision Instrument Corp. (1996) Summary page 1.
- K951574: EC-3800L, Video Colonoscope, Pentax Precision Instrument Corp. (1996) Summary page 1.
- K932843: Flexible Video Sigmoidoscope System W/Disp. Sheath, Vision-Sciences, Inc. (1994) Summary page 1.
- K933247: Protective Sheath for Flexible Nasophary/Larygnos, Vision-Sciences, Inc. (1993) Summary page 1.
- K921690: Flexible Fiberoptic Sigmoidoscope System, Vision-Sciences, Inc. (1992) Summary page 1.
- K921244: Disposable Protective Sheath, Vision-Sciences, Inc. (1992) Summary page 1.
- K944759: 200 Series Gastro-Intestinal Video System, Fujinon, Inc. (1995) Summary page 1.
- K933906: Choledochoscope/Endoscope Modification, Fujinon, Inc. (1994) Summary page 1.
- K954704: VS-200 Video Sigmoidoscope, Welch Allyn, Inc. (1996) Summary page 1.
- K950429: Video Sigmoidoscope, Welch Allyn, Inc. (1995) Summary page 1.
- K801247: CCD Endoscope and Attachments, Welch Allyn, Inc. (1980) Summary page 1.

## Indications for use
The akos endoscope system is used to examine body cavities, -hollow organs and canals, specifically the lower Gl tract (colon) only, and, using additional accessories, to perform various diagnostic and therapeutic praocedures.

Source page: https://510kreport.com/device/K964131
Methodology: https://510kreport.com/methodology