Skip to content

Sapimed Disposable Sigmoidoscope

by Sapimed S.P.A.

510(k) K070915

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK070915 Date6 Jul 2007ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1901-2021 FDA Class II initiated 23 Apr 2021

    Due to issue with product sterility. Sterilization service provider had falsified records.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KDM
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sapimed Disposable Sigmoidoscope is a rigid, non-electrical sigmoidoscope used for the examination of the rectum and sigmoid colon. This device is designed to provide visualization of the lower gastrointestinal tract during clinical procedures.

This device is supplied as a single-use instrument and is regulated under FDA 510(k) clearance K070915. It is classified as a class 2 medical device under regulation number 876.1500 for use in gastroenterology and urology.

Other devices from Sapimed S.P.A.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the Sapimed Disposable Sigmoidoscope?

    This device is a rigid, non-electrical instrument specifically designed to provide visualization of the lower gastrointestinal tract, including the rectum and sigmoid colon, during clinical procedures.

  • Is the Sapimed Disposable Sigmoidoscope intended for multiple uses?

    No, this device is supplied as a single-use instrument. It is designed to be disposed of after a single clinical procedure to ensure patient safety and eliminate the need for reprocessing.

  • What is the regulatory status of this sigmoidoscope?

    The Sapimed Disposable Sigmoidoscope is regulated under FDA 510(k) clearance K070915. It is classified as a class 2 medical device under regulation number 876.1500 for use in gastroenterology and urology.