Iogyn, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Iogyn, Inc. makes
Iogyn, Inc. manufactures reusable endoscopes and associated systems designed for gynecological examinations and procedures, including hysteroscopy and laparoscopy. These devices are intended for internal visualization and minimally invasive interventions in female reproductive health settings.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. These devices are listed in the FDA’s 510(k) database and are intended for use in the United States.
Catalogue
Iogyn Endoscope Ref K123330
Regimes: 510(k) Registry: 510(k)Iogyn System Ref K141848
Regimes: 510(k) Registry: 510(k)Iogyn System Ref DEN130040
Regimes: De Novo Registry: De Novo
Frequently asked questions
How many devices does Iogyn, Inc. have in the registry?
The registry currently lists 3 devices for Iogyn, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Iogyn, Inc.'s devices?
Among its 3 most recently registered devices, Iogyn, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Iogyn, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Iogyn, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Iogyn, Inc. in the registry?
The most recently registered devices listed for Iogyn, Inc. include IOGYN ENDOSCOPE and IOGYN SYSTEM.