- AustraliaNorth AmericaWorld
Investing News NetworkYour trusted source for investing success
- Lithium Outlook
- Oil and Gas Outlook
- Gold Outlook Report
- Uranium Outlook
- Rare Earths Outlook
- All Outlook Reports
- Top Generative AI Stocks
- Top EV Stocks
- Biggest AI Companies
- Biggest Blockchain Stocks
- Biggest Cryptocurrency-mining Stocks
- Biggest Cybersecurity Companies
- Biggest Robotics Companies
- Biggest Social Media Companies
- Biggest Technology ETFs
- Artificial Intellgience ETFs
- Robotics ETFs
- Canadian Cryptocurrency ETFs
- Artificial Intelligence Outlook
- EV Outlook
- Cleantech Outlook
- Crypto Outlook
- Tech Outlook
- All Market Outlook Reports
- Cannabis Weekly Round-Up
- Top Alzheimer's Treatment Stocks
- Top Biotech Stocks
- Top Plant-based Food Stocks
- Biggest Cannabis Stocks
- Biggest Pharma Stocks
- Longevity Stocks to Watch
- Psychedelics Stocks to Watch
- Top Cobalt Stocks
- Small Biotech ETFs to Watch
- Top Life Science ETFs
- Biggest Pharmaceutical ETFs
- Life Science Outlook
- Biotech Outlook
- Cannabis Outlook
- Pharma Outlook
- Psychedelics Outlook
- All Market Outlook Reports
Apollo Endosurgery Receives Special 510(k) Clearance for OverStitch Sx Endoscopic Suturing System
Apollo Endosurgery (Nasdaq:APEN) a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, announced today that it has received Special 510(k) clearance from the U.S. Food and Drug Administration for OverStitch™ Sx Endoscopic Suturing System. As quoted in the press release: The OverStitch Sx System, a new, full-thickness flexible endoscopic suturing system, …
Apollo Endosurgery (Nasdaq:APEN) a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, announced today that it has received Special 510(k) clearance from the U.S. Food and Drug Administration for OverStitch™ Sx Endoscopic Suturing System.
As quoted in the press release:
The OverStitch Sx System, a new, full-thickness flexible endoscopic suturing system, received initial 510(k) clearance in November 2017. The Special 510(k) addressed an accessory to the system that is intended to ease the attachment of the device to compatible endoscopes (single-channel endoscopes with diameters ranging from 8.8mm to 9.8mm). The Special 510(k) clearance is the last regulatory requirement needed prior to the system’s introduction into the US market.
Flexible endoscopic suturing using Apollo’s current version of OverStitch™ is an important tool for both surgeons and gastroenterologists, but it is currently only compatible with a limited number of dual-channel endoscopes and physicians without access to this specific capital equipment cannot leverage the benefits of endoscopic suturing.
Latest News
Investing News Network websites or approved third-party tools use cookies. Please refer to the cookie policy for collected data, privacy and GDPR compliance. By continuing to browse the site, you agree to our use of cookies.