LM- LAP 10 HIGH FLOW INSUFFLATOR— 510(k) K914201

Name: FDA 510(k) clearance K914201
Creator: U.S. Food and Drug Administration
Published: 1992-01-09

Substantially Equivalent

Leisegang Medical, Inc.

FDA 510(k) clearance K914201 for LM- LAP 10 HIGH FLOW INSUFFLATOR, Substantially Equivalent on 1992-01-09. Applicant: Leisegang Medical, Inc.. Device class: 2.

Clearance details

Applicant: Leisegang Medical, Inc.
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 1991-09-19
Decision date: 1992-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

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K250388 — ENDOFLATOR +2025-09-22
K242772 — AirSurgN Insufflator (10030/AirSurgN)2025-04-11

More clearances from Leisegang Medical, Inc.

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K990043 — SMOOTHLASE ALEXANDRITE LASER SYSTEM1999-02-11
K940094 — COLPOSCOPES AND ACCESSORIES1995-04-25
K924134 — LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS1993-07-02
K920217 — MAX-E-VAC1992-07-23
K912789 — LM-100/200LOW FLOW INSUFFLATOR1991-09-20

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.