OP-PNEU ELECTRONIC CO2— 510(k) K941438

Name: FDA 510(k) clearance K941438
Creator: U.S. Food and Drug Administration
Published: 1995-05-11

Substantially Equivalent

Wisap/U.S.A.

FDA 510(k) clearance K941438 for OP-PNEU ELECTRONIC CO2, Substantially Equivalent on 1995-05-11. Applicant: Wisap/U.S.A.. Device class: 2.

Clearance details

Applicant: Wisap/U.S.A.
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 1994-03-24
Decision date: 1995-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Munchen,, DE

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

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.