Welcon, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Welcon, Inc. makes
Welcon, Inc. manufactures sterile irrigation solutions, including sterile water and 0.9% normal saline for medical device use, as well as sterile irrigating syringes, kits, and procedure trays. Their portfolio also includes specialized products like the Welcon Light Handle, Welcon Hue-Vu urinary drainage bag, and sterile catheterization procedure trays. Additional offerings include women and infant delivery packs and the Accorde irrigating syringe/procedure tray.
The company’s products are regulated under FDA Class I and Class II devices, with several listed via the 510(k) pathway. These items are intended for use in medical procedures requiring irrigation, drainage, or catheterization. Welcon, Inc. is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Welcon Light Handle Ref K894397
Regimes: 510(k) Registry: 510(k)Welcon Hue-Vu Urinary Drainage Bag Ref K971764
Regimes: 510(k) Registry: 510(k)Sterile Catherization Procedure Trays Ref K830359
Regimes: 510(k) Registry: 510(k)Welcon Sterile Water For Device Irrigation; Welcon Sterile 0.9% Normal Saline For Device Irrigation Ref K003402
Regimes: 510(k) Registry: 510(k)Sterile Irrigating Syringes, Kits, Tray Ref K813027
Regimes: 510(k) Registry: 510(k)Women And Infant's Delivery Pack Ref K912869
Regimes: 510(k) Registry: 510(k)Accorde(R) Irrigating Syringe/Procedure Tray Ref K904158
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Welcon, Inc. have in the registry?
The registry currently lists 8 devices for Welcon, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Welcon, Inc.'s devices?
Among its 8 most recently registered devices, Welcon, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Welcon, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Welcon, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Welcon, Inc. in the registry?
The most recently registered devices listed for Welcon, Inc. include STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION, WELCON LIGHT HANDLE, WELCON HUE-VU URINARY DRAINAGE BAG and STERILE CATHERIZATION PROCEDURE TRAYS.