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Endcup

by Lewtek

510(k) K945862

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK945862 Date23 Feb 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Endcup is a laparoscope accessory designed for general and plastic surgery procedures, as classified under FDA regulation 876.1500. It is intended for use in minimally invasive surgical applications, particularly within the fields of gastroenterology and urology, where precise tissue manipulation and visualization are required.

Supplied as a reusable medical device, the Endcup is intended for single-patient use in controlled surgical environments. It is not intended for MRI use and must be cleaned, disinfected, and sterilized between procedures according to established protocols. Authorized under FDA 510(k) clearance (K945862) with a classification of Substantially Equivalent (SESE), the device adheres to regulatory standards for surgical accessories in Class II medical devices.

Questions

AI-generated answers, 1 Oct 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 Endcup laparoscope accessory used for?

    The Endcup is designed as a laparoscope accessory for general and plastic surgery, specifically in minimally invasive procedures within gastroenterology and urology. It helps surgeons achieve precise tissue manipulation and improved visualization during operations where delicate handling is critical.

  • Is the Endcup intended for single-use or reusable?

    The Endcup is supplied as a reusable medical device but is intended for single-patient use in controlled surgical environments. After each procedure, it must be thoroughly cleaned, disinfected, and sterilized to ensure safety for subsequent uses.

  • Can the Endcup be used in MRI environments?

    No, the Endcup is explicitly not intended for MRI use. Its design and materials are not compatible with magnetic resonance imaging, so it should only be used in non-MRI surgical settings.

  • What regulatory clearance does the Endcup hold?

    The Endcup holds FDA 510(k) clearance under the reference number K945862, classified as Substantially Equivalent (SESE). This clearance confirms its compliance with regulatory standards for surgical accessories in Class II medical devices.

  • How should the Endcup be stored between uses?

    Between uses, the Endcup must be stored in a clean, dry environment following manufacturer guidelines to maintain sterility and functionality. Ensure it is properly disinfected and sterilized before reuse to prevent contamination and ensure safe surgical use.