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Self-Light Disposable Anoscope

by Sapimed S.P.A.

510(k) K070913

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K070913↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK070913 Date10 Aug 2007ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

1 recall · FDA

    • Terminated Z-1901-2021 FDA Class II initiated 23 Apr 2021 on shared 510(k) K070913

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

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

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

Overview

AI-generated summary, 18 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 Self-Light Disposable Anoscope is a single-use, self-illuminated device designed for visual examination of the anal canal and surrounding perianal tissues. It falls under the category of anoscopes and accessories, providing direct visualization for diagnostic and minor therapeutic procedures in gastroenterology and urology.

This device is supplied as a sterile, disposable instrument, intended for use in outpatient settings, hospital wards, or home environments. It incorporates a battery-operated pen light for enhanced illumination and is classified as a Class II medical device under FDA regulations (K070913, 510(k) clearance). Multiple model variants are available, each adhering to regulatory standards for single-use medical instruments.

Other devices from Sapimed S.P.A.

Questions

AI-generated answers, 18 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 types of clinical procedures is the Self-Light Disposable Anoscope primarily used for?

    The Self-Light Disposable Anoscope is designed for visual examination of the anal canal and surrounding perianal tissues, making it useful for diagnostic and minor therapeutic procedures in gastroenterology and urology. Its built-in battery-operated pen light enhances visibility, aiding in accurate assessments during these procedures.

  • Is this anoscope reusable, or is it intended for single-use only?

    This device is explicitly labeled as a single-use anoscope, meaning it is intended for one-time use only. The sterile packaging ensures safety for each procedure, and it is not designed for reprocessing or reuse.

  • How many model variants of the Self-Light Disposable Anoscope are available, and what does this mean for purchasing?

    Multiple model variants exist for the Self-Light Disposable Anoscope, as indicated by the listed registration numbers (e.g., 3009526575, 3013557562, etc.). This variety allows buyers to select the specific variant that best fits their clinical needs, though all adhere to the same regulatory standards for single-use medical instruments.

  • Where can this device be used, and what settings are appropriate for its application?

    The Self-Light Disposable Anoscope is supplied sterile and designed for use in outpatient settings, hospital wards, or home environments. Its disposable, self-illuminated design makes it practical for flexible deployment across different care settings where anal canal examinations are required.

  • How is the device’s regulatory status confirmed, and what does the FDA clearance indicate?

    The device holds FDA 510(k) clearance (K070913) under the classification of an Anoscope and Accessories, with a decision labeled as *Substantially Equivalent*. This means it has been reviewed by the FDA and deemed comparable to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for its intended use.