# K963344: Disposable SS-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic Sigmoidoscope

- Pathway: 510(k) (Traditional)
- Applicant: Vision-Sciences, Inc.
- Decided: Nov 21, 1996 after 87 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). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921690: Flexible Fiberoptic Sigmoidoscope System, Vision-Sciences, Inc. (1992) Summary page 1.
- K961591: Disposable Endosheath for E-F100 Flexible Nasopharyngoscope, Vision-Sciences, Inc. (1996) Summary page 1.
- K943895: Vision System Colonscope, Vision-Sciences, Inc. (1995) 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”.

## Most influential descendants
- K061663: Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for Otolaryngoscopes and Bronchoscopes (2006), 0 descendants of its own
- K061324: Emt Quik-Cover Flexible Endoscope Barrier Sheath, Series 1-7 (2006), 0 descendants of its own

## 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/K963344
Methodology: https://510kreport.com/methodology