510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Sakura Seiki Co., Ltd.

CHIKUMA-CITY Nagano, JP

SAKURA SEIKI CO., LTD. appears in FDA device records in CHIKUMA-CITY Nagano, JP. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Sakura Seiki Co., Ltd. between 2012 and 2014. The busiest year on record is 2012, with 1. The most recent is 2014, with 1.

Clearances by year, as a table
510(k) clearance decisions for Sakura Seiki Co., Ltd., by decision year
YearClearances
20121
20131
20141
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K132439SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZERFLESubstantially Equivalent
K122774SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEGFLESubstantially Equivalent
K120149SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURAFLESubstantially Equivalent

Registered establishments

FDA registered establishments for Sakura Seiki Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10003033551000303355SAKURA SEIKI CO., LTD.75-5 IMOJIYA, CHIKUMA-CITY Nagano 387-0015 JP2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain