Hirata Sangyo Co. USA, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Hirata Sangyo Co. USA, Inc. makes
Hirata Sangyo Co. USA, Inc. manufactures surgical instruments, syringe pumps, and manual surgical tools, including specific models like the SR-Model 230 and its modifications, as well as specialized devices such as the GP-303 and non-stethoscope instruments like the NON-STETHO 7 and UM-15TP.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products listed via the 510(k) pathway. The manufacturer operates in the United States.
Catalogue
Surgical Instrument Ref K833541
Regimes: 510(k) Registry: 510(k)Syringe Pump Ref K822571
Regimes: 510(k) Registry: 510(k)Multiple Manual Surgical Instruments Ref K832686
Regimes: 510(k) Registry: 510(k)Sr-Model 230 (Modification) Ref K864106
Regimes: 510(k) Registry: 510(k)Sr- Model 230 Ref K842289
Regimes: 510(k) Registry: 510(k)Non-Stetho 7, Um-15TP Ref K821989
Regimes: 510(k) Registry: 510(k)Surgical Instrument Ref K833542
Regimes: 510(k) Registry: 510(k)Gp-303 Ref K831583
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hirata Sangyo Co. USA, Inc. have in the registry?
The registry currently lists 8 devices for Hirata Sangyo Co. USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hirata Sangyo Co. USA, Inc.'s devices?
Among its 8 most recently registered devices, Hirata Sangyo Co. USA, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Hirata Sangyo Co. USA, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Hirata Sangyo Co. USA, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hirata Sangyo Co. USA, Inc. in the registry?
The most recently registered devices listed for Hirata Sangyo Co. USA, Inc. include SURGICAL INSTRUMENT, SYRINGE PUMP, MULTIPLE MANUAL SURGICAL INSTRUMENTS and SR-MODEL 230 (MODIFICATION).