Surgidyne, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Surgidyne, Inc. makes
Surgidyne, Inc. manufactures suction drainage systems, including battery-powered and cordless electric models like the VARIDYNE 350-2I and 350-2C, as well as wall-mounted and portable suction units such as the VARIDYNE 550 (models 12E, 12M, 24E, and 24M). The company also produces surgical drainage tubes, including the Leonard Tube, and continuous wound suction drainage products under the SURGIFLO C.W.S. line.
These devices are classified under FDA’s Class I and Class II categories and are subject to 510(k) clearance requirements. The manufacturer is based in the United States and its products are listed in the FDA’s 510(k) registry.
Catalogue
Varidyne Model 250 Suction Drainage System Ref K883582
Regimes: 510(k) Registry: 510(k)Surgidyne Varidyne, Model 140-2I & Model 140-2ID Ref K860030
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Leonard Tube Ref K892334
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Surgidyne Surgiflo C.W.S. Drain Products Ref K850634
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Surgidyne, Inc. have in the registry?
The registry currently lists 6 devices for Surgidyne, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Surgidyne, Inc.'s devices?
Among its 6 most recently registered devices, Surgidyne, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Surgidyne, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Surgidyne, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Surgidyne, Inc. in the registry?
The most recently registered devices listed for Surgidyne, Inc. include VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM, SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID, SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC. and LEONARD TUBE.