ClearanceBrief
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)
Get daily alerts for HIFSample briefCSV

Top companies in HIF

DateFirm and productCodeLinked 510(k)
Jul 22, 2026Olympus Corporation of the Americas
Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Open, Classified
HIFK243527
Jun 17, 2026ConMed 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
HIFK143404
Jun 17, 2026ConMed 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
HIFK143404
Jun 17, 2026ConMed 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
HIFK143404
Jun 17, 2026ConMed 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
HIFK143404
Jun 17, 2026ConMed 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
HIFK143404
Jun 17, 2026ConMed 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
HIFK143404
Jun 17, 2026ConMed 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
HIFK143404
Jun 17, 2026ConMed 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
HIFK143404
Jun 17, 2026ConMed 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
HIFK143404
Jun 17, 2026ConMed 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
HIFK143404
Jun 17, 2026ConMed 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
HIFK143404
Feb 18, 2026Olympus 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
HIFK014166
Feb 18, 2026Olympus 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
HIFK953162
Feb 18, 2026Olympus 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
HIFK953162
Mar 25, 2024Olympus Corporation of the Americas
Insufflation unit, UHI-4.
Open, Classified
HIFK110294
Oct 18, 2023Olympus Corporation of the Americas
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Open, Classified
HIFK110294
K122180
Jan 15, 2021Northgate 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
HIFK120151
Jul 27, 2020Richard 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
HIFK000180
Mar 7, 2019Stryker 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
HIFK003792
Mar 7, 2019Stryker 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
HIFK063367
Mar 7, 2019Stryker Corporation
Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
Terminated
HIFK063367
Oct 22, 2018WOM 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
HIFK170784
Mar 11, 2018Richard Wolf GmbH
RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.
Terminated
HIFK000180
Nov 21, 2016Northgate 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
HIFK120151
Mar 28, 2016Stryker 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
HIFK063367
Jul 24, 2015EXP 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
HIFNone listed
Mar 23, 2010Stryker Endoscopy
Pnemosure Insufflators, model numbers 620-040-600 and 620-040-610, manufactured by Stryker Endoscopy, San Jose, CA.
Terminated
HIFK063367
Aug 24, 2006Richard 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
HIFK000180

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.