# K070915: Sapimed Disposable Sigmoidoscope

- Pathway: 510(k) (Traditional)
- Applicant: Sapimed S.P.A.
- Decided: Jul 6, 2007 after 95 days
- Product code: KDM (Sigmoidoscope, Rigid, Non-Electrical)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K770291 (1977). 1 ancestor in all.
9 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K770291: Sigmoidoscope, Disposable, Model #53125, Welch Allyn, Inc. (1977) Summary page 1.

## Most influential descendants
- K080132: THD Disposable Anoscope/Proctoscope (2008), 6 descendants of its own
- K091490: Family of THD Disposable Anoscopes/Proctoscopes/Rectoscopes (2009), 4 descendants of its own
- K103647: THD Disposable Anoscopes, Proctoscopes and Rectoscopes (2011), 3 descendants of its own
- K133393: Gelpoint Path Transanal Access Platform (2014), 1 descendant of its own
- K121135: THD Anoscope, Proctoscope, Rectoscope, Rectoscope and Light-Scope (2012), 1 descendant of its own

## Recalls of this device
- Apr 23, 2021 · Class II · Z-1901-2021: Due to issue with product sterility. Sterilization service provider had falsified records.

## Indications for use
SAPIMED's Sigmoidoscopes are used to examine the rectum and lower bowel and, using additional accessories, perform various diagnostic and/or therapeutic procedures.

Source page: https://510kreport.com/device/K070915
Methodology: https://510kreport.com/methodology