Innerdyne Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Innerdyne Medical, Inc. makes
Innerdyne Medical, Inc. manufactures single-stick radially expanding dilators for endoscopic procedures, including biliary and pancreatic interventions, as well as expandable trocar ports for laparoscopic access. Their product line includes a sphincterotomy kit designed for controlled incision of the sphincter of Oddi and radially expanding introducers for catheter placement. These devices are intended for use in minimally invasive surgical and interventional radiology settings.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. Their products are listed in the FDA’s 510(k) database, reflecting compliance with U.S. medical device authorization requirements. The manufacturer operates from the United States.
Catalogue
Innerdyne Step Trocar Expandable Port, S.T.E.P. Ref K943253
Regimes: 510(k) Registry: 510(k)Innerdyne Step Trocar Expandable Port, S.T.E.P. Ref K940232
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Single Stick Radially Expanding Dilator Ref K943056
Regimes: 510(k) Registry: 510(k)Intherm Radially Expanding Dilating Introducer Ref K931489
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Innerdyne Medical, Inc. have in the registry?
The registry currently lists 6 devices for Innerdyne Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Innerdyne Medical, Inc.'s devices?
Among its 6 most recently registered devices, Innerdyne Medical, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Innerdyne Medical, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Innerdyne Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Innerdyne Medical, Inc. in the registry?
The most recently registered devices listed for Innerdyne Medical, Inc. include INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P., INNERDYNE MEDICAL LAPAROSCOPIC SPHINCTEROTOMY KIT, INNERDYNE SINGLE-STICK RADIALLY EXPANDING DILATOR and SINGLE STICK RADIALLY EXPANDING DILATOR.