Apollo Overstitch for Endoscopic Bariatric Interventions
Device Name: Apollo Overstitch for Endoscopic Bariatric Interventions Author(s): Timothy Snow, DO, FACS, FASMBS Apollo Endosurgery received FDA approval for Apollo ESG and Apollo REVISE Systems on July 12, 2022. Primary Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic procedure performed by surgeons and gastroenterologists utilizing the Apollo ESG System for obese patients with a BMI […]
SDC4K Information Management System with Device and Voice Control Package
Device Name: SDC4K Information Management System with Device and Voice Control Package Author: Nova Szoka MD FACS FASMBS Stryker Endoscopy received FDA approval for the SDC4K Information Management System with Device and Voice Control Package on February 9, 2022. The SDC4K Information Management System with Device and Voice Control Package is a network compatible hardware […]
EvoEndo Single-use Endoscopy System
Author(s): Andrew Luhrs, MD EvoEndo Inc. received FDA approval for EvoEndo Single-use Endoscopy System on February 14, 2022. The EvoEndo Model LE Gastroscope is a sterile, single use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult and pediatric patients. It has a 3.5mm outer diameter, 2mm working channel (compatible with standard accessories), and […]
8 mm SureForm 30 Staplers and Reloads
Intuitive Surgical, Inc. received FDA approval for the 8 mm SureForm 30 Stapler on December 10, 2021 (K211997). The 8mm SureForm 30 Stapler is a disposable, fully wristed, four-row, variable height stapler system with 120 degree articulation and SmartFire tissue compression sensors for use with the DaVinci surgical system during the resection, transection, and anastomoses […]
eXciteOSA
Authors: Tejas Nikumbh MD, Nova Szoka MD, FACS, FASMBS Signifier Medical Technologies received FDA approval by the DeNovo pathway for the eXciteOSA neuromuscular tongue stimulator in February 2021. The eXciteOSA is a removable device that delivers neuromuscular stimulation to the tongue to reduce snoring and mild obstructive sleep apnea. Treatment takes twenty minutes a day […]
Ethicon Megadyne™ Electrosurgical Generator
Author(s): Michael Josephson, MD, Kate Lak, MD Medical College of Wisconsin Ethicon received FDA approval for the Megadyne Electrosurgical Generator K213696 on January 21, 2022. The Megadyne™ Electrosurgical Generator K213696 is new iteration in the line of Ethicon Megadyne™ Electrosurgical Generators. It is intended to be used as a general-purpose electrosurgical generator for use in […]
PK Electrosurgical Instruments: PK Needle, PK Spatula, and PK J-Hook
Olympus received FDA approval for PK Electrosurgical Instruments: PK Needle, PK Spatula, and PK J-Hook on January 4, 2022. The PK Electrosurgical Instruments, including Needle, Spatula, and J-Hook are classified as electrosurgical cutting and coagulation surgical devices and accessories. These impedance controlled devices are compatible with the Olympus ESG-400 and ESG-410 generators. These devices decrease […]
Ambu® aScope™ Gastro and Ambu® aBox™ 2
Ambu® aScope™ is a sterile single-use gastroscope which was released in conjunction with Ambu® aBox™ 2, a next-generation display with advanced processing technology offering high quality images during endoscopic procedures. In 2005, the American College of Chest Physicians published a consensus statement on the Prevention of Flexible Bronchoscopy-Associated Infection.1 Since then, there has been a […]
Author(s): Matthew Burstein, MD, PhD, Marissa Novack, MD, Alan Posner, MD Human Xtensions Ltd. received FDA approval for the HandX Monopolar Hook on February 1, 2021 (K203603). The HandX platform allows for motorized 85 degree articulation across 4 degrees of freedom, and up to 540 degrees of rotation through conventional 5 mm laparoscopic ports, directly […]
Author(s): Kevin Carroll, MBBS, David Pechman, MD Boston Scientific received FDA approval for the EXALT Model B Single-Use Bronchoscope on August 10th, 2021 The EXALT Model B Bronchoscope is a single-use bronchoscope developed as an alternative to reusable bronchoscopes. This bronchoscope has superior quality imaging and suctioning (up to 78% improved) which is vital for […]