Skip to content

Multiple Instrument Guide

by Lap Surgical Systems, LLC

510(k) K022686

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 NumberK022686 Date25 Nov 2002ClearedStatusActive

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  • Withdrawn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)

Full name
Lap Surgical Systems Multiple Instrument Guide
510(k) Number
FDA Product Code
FED
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 Multiple Instrument Guide is an Endoscopic Access Overtube, designed to facilitate the insertion of surgical instruments and choledochoscopes into the common bile duct during laparoscopic procedures. It serves as a conduit for multiple instruments, enabling precise access and manipulation within the biliary system for diagnostic and therapeutic interventions.

This device is intended for single-use in controlled surgical environments, adhering to sterile procedures. It is classified as a Class II medical device under FDA regulations (21 CFR 876.1500) and holds an FDA 510(k) clearance (K022686) for use in Gastroenterology and Urology specialties. Multiple sizes and configurations are available, as referenced by the associated FEI numbers, ensuring compatibility with various laparoscopic setups. Storage and handling must comply with standard surgical instrument protocols.

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 Multiple Instrument Guide used for?

    The Multiple Instrument Guide is an Endoscopic Access Overtube designed specifically for laparoscopic procedures. It facilitates the insertion of surgical instruments and choledochoscopes into the common bile duct, providing a conduit for precise access and manipulation during diagnostic or therapeutic interventions in the biliary system.

  • How is the Multiple Instrument Guide supplied and what are its sterility requirements?

    The Multiple Instrument Guide is supplied as a single-use device, adhering strictly to sterile surgical protocols. It is intended for controlled surgical environments where sterility is maintained throughout the procedure to ensure patient safety and device efficacy.

  • Are there different sizes or configurations available for this device?

    Yes, the Multiple Instrument Guide comes in multiple sizes and configurations, each referenced by unique FEI numbers. These variations ensure compatibility with a wide range of laparoscopic setups, accommodating different procedural needs in Gastroenterology and Urology.

  • How should the Multiple Instrument Guide be stored?

    Storage and handling of the Multiple Instrument Guide must comply with standard surgical instrument protocols. This includes maintaining sterility, proper packaging, and adherence to manufacturer guidelines to preserve functionality and ensure readiness for single-use in surgical environments.

  • Is the Multiple Instrument Guide reusable?

    No, the Multiple Instrument Guide is explicitly designed for single-use only. This design choice aligns with best practices for minimizing infection risks and ensuring consistent performance during surgical procedures.