# K964100: Vision-Sciences Model SS-U32 Endo Sheath for Use with the Vsi S-F100 Flexible Fiberoptic Sigmoidoscope and Vsi S-V100

- Pathway: 510(k) (Traditional)
- Applicant: Vision-Sciences, Inc.
- Decided: Dec 16, 1996 after 66 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 K921244 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932843: Flexible Video Sigmoidoscope System W/Disp. Sheath, Vision-Sciences, Inc. (1994) Summary page 1.
- K921690: Flexible Fiberoptic Sigmoidoscope System, Vision-Sciences, Inc. (1992) Summary page 1.
- K943895: Vision System Colonscope, Vision-Sciences, Inc. (1995) Summary page 1.
- K961591: Disposable Endosheath for E-F100 Flexible Nasopharyngoscope, Vision-Sciences, Inc. (1996) Summary page 1.
- K950809: Vision-Sciences Disposable Endosheath for Flexible Nasopharyngo-Laryngoscopes, Vision-Sciences, Inc. (1996). Our OCR of the scanned summary read K951809, FDA’s number for Gliding Nail (Encore Orthopedics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “EndoSheaths for use with Machida, Pentax and Olympus ENT Scopes”.

## Indications for use
The EndoSheath provides a sterile, disposable protective covering for the scope to be used during endoscopic examination of the sigmoid colon.

Source page: https://510kreport.com/device/K964100
Methodology: https://510kreport.com/methodology