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Success Cecal Intubation Assist, Model 4100

by Max Endoscopy, Inc.

510(k) K080764

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 NumberK080764 Date6 May 2008ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 23 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 Success Cecal Intubation Assist, Model 4100 is an endoscope channel accessory designed to assist in cecal intubation during gastrointestinal procedures. It is classified as a Class II medical device and is intended for use in gastroenterology and urology procedures.

The device is supplied by Max Endoscopy, Inc. and has received FDA 510(k) clearance with the number K080764. It is regulated under product code ODC and regulation number 876.1500. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.

Other devices from Max Endoscopy, Inc.

Questions

AI-generated answers, 23 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 Success Cecal Intubation Assist Model 4100 used for?

    The Success Cecal Intubation Assist, Model 4100 is an endoscope channel accessory designed to assist in cecal intubation during gastrointestinal procedures. It is intended for use in gastroenterology and urology procedures to help facilitate reaching the cecum during endoscopic examinations.

  • Is the Success Cecal Intubation Assist Model 4100 single-use or reusable?

    The device data does not specify whether the Success Cecal Intubation Assist, Model 4100 is designed for single-use or reusable applications. No information regarding sterility status is provided in the available data.

  • What regulatory approvals does the Success Cecal Intubation Assist Model 4100 have?

    The Success Cecal Intubation Assist, Model 4100 has received FDA 510(k) clearance with number K080764. It is classified as a Class II medical device under product code ODC and regulation number 876.1500, and is regulated under the gastroenterology and urology advisory committee.

  • How is the Success Cecal Intubation Assist Model 4100 supplied?

    The device is supplied by Max Endoscopy, Inc. However, the available data does not provide specific information regarding packaging, quantities per package, or storage conditions for the Success Cecal Intubation Assist, Model 4100.