INSITE MODEL 20 & MODEL 15 INSUFFLATORS— 510(k) K934926

Name: FDA 510(k) clearance K934926
Creator: U.S. Food and Drug Administration
Published: 1994-05-26

Substantially Equivalent

Andronic Devices, Ltd.

FDA 510(k) clearance K934926 for INSITE MODEL 20 & MODEL 15 INSUFFLATORS, Substantially Equivalent on 1994-05-26. Applicant: Andronic Devices, Ltd.. Device class: 2.

Clearance details

Applicant: Andronic Devices, Ltd.
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 1993-10-14
Decision date: 1994-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, B.C. Canada V6v 2j2, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIF

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K260209 — ENDOFLATOR+; Smart Smoke Evacuation2026-08-19
K252584 — Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)2026-06-25
K252318 — Insufflator (OPTO-IFL1000)2026-04-16
K250388 — ENDOFLATOR +2025-09-22
K242772 — AirSurgN Insufflator (10030/AirSurgN)2025-04-11

More clearances from Andronic Devices, Ltd.

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K940812 — INSIGHT ELECTRONIC ALIGNMENT INDICATOR1994-11-21
K934928 — INSITE FILTER & TUBING SET1994-05-26
K935381 — KAPS POSITIONING ARM1994-04-15
K934124 — AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM1994-04-13
K936308 — ENDEX ENDOSCOPIC POSITIONING SYSTEM1994-03-31

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.