Panels › Obstetrics/Gynecology › Product code HIF · Class 2
Insufflator, Laparoscopic
Regulation 884.1730
3510(k)s in 12 months (179 all time)
15recalls in 12 months (29 all time)
28recalls that name a 510(k)
Top companies in HIF
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2026 | Olympus Corporation of the Americas Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 Open, Classified |
HIF | K243527 |
| Jun 17, 2026 | ConMed Corporation ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS12-100LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxi Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS12-120LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dio Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. Catalog Number: iAS12-150LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxi Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxid Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS5-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxid Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Catalog Number: iAS5-75LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS8-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxid Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS8-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxid Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Lapar Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Lapa Open, Classified |
HIF | K143404 |
| Jun 17, 2026 | ConMed Corporation ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Open, Classified |
HIF | K143404 |
| Feb 18, 2026 | Olympus Corporation of the Americas Olympus High Flow Insufflation Unit. Model Number: UHI-3.
Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatme Open, Classified |
HIF | K014166 |
| Feb 18, 2026 | Olympus Corporation of the Americas Olympus High Flow Insufflation Unit. Model/ Number: UHI-2.
Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatm Open, Classified |
HIF | K953162 |
| Feb 18, 2026 | Olympus Corporation of the Americas Olympus High Flow Insufflation Unit. Model Number: UHI.
Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment Open, Classified |
HIF | K953162 |
| Mar 25, 2024 | Olympus Corporation of the Americas Insufflation unit, UHI-4. Open, Classified |
HIF | K110294 |
| Oct 18, 2023 | Olympus Corporation of the Americas Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery. Open, Classified |
HIF | K110294 K122180 |
| Jan 15, 2021 | Northgate Technologies, Inc. ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical ins Terminated |
HIF | K120151 |
| Jul 27, 2020 | Richard Wolf GmbH Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and access Terminated |
HIF | K000180 |
| Mar 7, 2019 | Stryker Corporation Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile. Terminated |
HIF | K003792 |
| Mar 7, 2019 | Stryker Corporation Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile. Terminated |
HIF | K063367 |
| Mar 7, 2019 | Stryker Corporation Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile. Terminated |
HIF | K063367 |
| Oct 22, 2018 | WOM World of Medicine AG 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. Terminated |
HIF | K170784 |
| Mar 11, 2018 | Richard Wolf GmbH RICHARD WOLF TUBE SET FOR TEM, REF 4170.801.
Used for the transanal endoscopic microsurgery. Terminated |
HIF | K000180 |
| Nov 21, 2016 | Northgate Technologies, Inc. Insufflator, laparoscopic
The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operati Terminated |
HIF | K120151 |
| Mar 28, 2016 | Stryker Endoscopy PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator;
High pressure units (HPU) (40L and 45L).
Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 62 Terminated |
HIF | K063367 |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange Insufflation Needle;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number C2201;
EXP (repackager), Medline (OEM)
Insufflator, laparoscopic Terminated |
HIF | None listed |
| Mar 23, 2010 | Stryker Endoscopy Pnemosure Insufflators, model numbers 620-040-600 and 620-040-610, manufactured by Stryker Endoscopy, San Jose, CA. Terminated |
HIF | K063367 |
| Aug 24, 2006 | Richard Wolf Medical Instruments Corp. Tubing Set for TEM-Combined System; the tube set consists of a rectal pressure measuring tube, an insufflation tube, an irrigation tube, a suction tube, a pump tube, and a connection tube; a sterile, Terminated |
HIF | K000180 |
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