PNEUMOCLEAR— 510(k) K170784

Name: FDA 510(k) clearance K170784
Creator: U.S. Food and Drug Administration
Published: 2017-05-15

Substantially Equivalent

W.O.M. World of Medicine GmbH

FDA 510(k) clearance K170784 for PNEUMOCLEAR, Substantially Equivalent on 2017-05-15. Applicant: W.O.M. World of Medicine GmbH. Device class: 2.

Clearance details

Applicant: W.O.M. World of Medicine GmbH
Product code: Code HIF
Device class: Class 2
Regulation: 21 CFR 884.1730
Advisory panel: Obstetrics/Gynecology
Date received: 2017-03-15
Decision date: 2017-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berlin, 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

More clearances from W.O.M. World of Medicine GmbH

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K250795 — PUREVUE FMS2025-12-05
K201361 — PNEUMOCLEAR2020-07-29
K173311 — ARTHRO-Pump PA3042018-05-09
K173489 — GYN-Pump PH3042018-03-28
K172040 — Aquilex Fluid Control System AQL-100S2018-02-05

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 →

Recalls naming K170784

K-number listed on FDA's recall record

Z-0508-2019 — PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vessel Harvest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using C02 gas during trans anal minimal invasive surgery.Class II·Terminated·WOM World of Medicine AG·20181022

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170784.

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