Data / Medical devices / Japan / Sakura Seiki Co., Ltd. Chikuma Factory
Sakura Seiki Co., Ltd. Chikuma Factory: FDA-registered device maker in Chikuma Nagano, Japan, 3 510(k) clearances
Sakura Seiki Co., Ltd. Chikuma Factory is registered with the FDA (registration 3009685834) in Chikuma Nagano, Japan. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated January 6, 2014. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3009685834
- Address
- 46-1 Shinden, Chikuma Nagano, Japan, 387-0018
- Owner or operator
- Sakura Seiki Co., Ltd Chikuma factory (10061941)
- Roles
- Manufacturer
- First device listed
- December 4, 2019
- Registered through
- 2026
- Brand names listed
- Integrity 270/270VP Steam Sterilizer, Sakura ASSV-AH06, Sakura Steam Sterilizer ASSR-AO12, Sakura Steam Sterilizer ASSR-AO12P, Sakura Steam Sterilizer ASSR-AO12PW, Sakura Steam Sterilizer ASSR-AO12W, Sakura Steam Sterilizer ASSV-AB09, Sakura Steam Sterilizer ASSV-AB09E and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sterilizer, Steam | FLE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 6, 2014 | K132439 | SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER | FLE | Substantially Equivalent | Sakura Seiki Co., Ltd. | accessdata.fda.gov |
| May 9, 2013 | K122774 | SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG | FLE | Substantially Equivalent | Sakura Seiki Co., Ltd. | accessdata.fda.gov |
| May 8, 2012 | K120149 | SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA | FLE | Substantially Equivalent | Sakura Seiki Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 6, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.