Imagyn Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 19
What Imagyn Medical, Inc. makes
Imagyn Medical, Inc. manufactures single-use laparoscopic and hysteroscopic instruments, including disposable laparoscopes (such as the IMAGYN MICROLAP and MICRO LAP-GOLD), introducers for minimally invasive procedures, and hysteroscopes with sheaths (e.g., MICROSPAN GOLD). The portfolio also includes specialized devices like the IMAGYN FALLOPOSCOPY SYSTEM, an intrauterine insemination device, and an inflation device with non-invasive pressure tubing for endoscopic procedures.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) clearance database. Products are listed in the US under the jurisdiction of the Food and Drug Administration.
Catalogue
Search and filter all 19 devicesFrequently asked questions
How many devices does Imagyn Medical, Inc. have in the registry?
The registry currently lists 19 devices for Imagyn Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Imagyn Medical, Inc.'s devices?
Among its 19 most recently registered devices, Imagyn Medical, Inc. has devices listed in FDA 510(k) (19 devices).
What risk classes do Imagyn Medical, Inc.'s devices fall under?
Among its 19 most recently registered devices, the classes recorded for Imagyn Medical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Imagyn Medical, Inc. in the registry?
The most recently registered devices listed for Imagyn Medical, Inc. include IMAGYN MICROLAP(TM) LAPAROSCOPE, IMAGYN MICROLAP INTRODUCER, IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES and MICROSPAN HYSTEROSCOPE SHEATH.