Ascep, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 9
What Ascep, Inc. makes
Ascep, Inc. manufactures reusable and sterile disposable surgical instruments, including instrument trays, scalpel blades, and specialized care kits for intravenous and catheter management. Their product line also covers central venous catheter dressing trays, suture removal trays, and sterile nonsterile instrument sets.
The company’s devices are classified under FDA Class I and Unclassified (U) categories, with many listed via the 510(k) pathway. Their products are registered with the FDA under U.S. regulatory requirements.
Catalogue
Various Instruments & Instrument Trays Ref K830219
510(k) 510(k)Sterile Disposable Instrument Trays Ref K810004
510(k) 510(k)G.E.V. Disposable Scalpels Ref K822893
510(k) 510(k)I.V. Start Set Ref K791885
510(k) 510(k)Central Venous Catheter Dressing Tray Ref K791887
510(k) 510(k)I.V. Care Kit Ref K791886
510(k) 510(k)Catheter Care Kit Reorder 7940&7941 Ref K791888
510(k) 510(k)Instruments Nonsterile & Sterile Ref K802726
510(k) 510(k)Suture Removal Tray, Reorder 7950&7951 Ref K791889
510(k) 510(k)
Frequently asked questions
How many devices does Ascep, Inc. have in the registry?
The registry currently lists 9 devices for Ascep, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ascep, Inc.'s devices?
Among its 9 most recently registered devices, Ascep, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Ascep, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Ascep, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Ascep, Inc. in the registry?
The most recently registered devices listed for Ascep, Inc. include VARIOUS INSTRUMENTS & INSTRUMENT TRAYS, STERILE DISPOSABLE INSTRUMENT TRAYS, G.E.V. DISPOSABLE SCALPELS and I.V. START SET.