Glenveigh Surgical, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Glenveigh Surgical, LLC makes
Glenveigh Surgical, LLC manufactures obstetric tamponade systems and vaginal tamponade balloon catheters designed to manage postpartum hemorrhage. These devices are intended for use in high-risk obstetric cases to control bleeding by applying pressure within the vaginal canal or uterine cavity.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are intended for use in the United States, where they are subject to compliance with the FDA’s regulatory requirements for Class II devices.
Catalogue
Belfort-Dildy Obstetric Tamponade System Ref K091958
Regimes: 510(k) Registry: 510(k)Glenveigh Vaginal Tamponade Balloon Catheter Ref K093904
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Glenveigh Surgical, LLC have in the registry?
The registry currently lists 2 devices for Glenveigh Surgical, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Glenveigh Surgical, LLC's devices?
Among its 2 most recently registered devices, Glenveigh Surgical, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Glenveigh Surgical, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Glenveigh Surgical, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Glenveigh Surgical, LLC in the registry?
The most recently registered devices listed for Glenveigh Surgical, LLC include BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM and GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER.