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LAP 3501 High Flow Insufflator

by Circon Acmi 510(k)

Active United States

510(k) K905705

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK905705 Date28 Feb 1991ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HIF
Device Class
Class II
Regulation
21 CFR Part 884.1730
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 LAP 3501 High Flow Insufflator is a laparoscopic insufflator designed to introduce carbon dioxide into the abdominal cavity during minimally invasive surgical procedures. It delivers controlled gas flow to create and maintain pneumoperitoneum, facilitating visualization and access for laparoscopic interventions in obstetrics and gynecology.

This device is intended for single-use and is regulated under FDA 510(k) clearance (K905705) with a classification of Class II. Supplied sterile, it operates within the constraints of regulation number 884.1730 and is intended for use in surgical settings requiring high-flow insufflation. The model number 3501 is explicitly referenced in its regulatory submission.

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