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

Suzhou Jiangsu, CN

ENDOCLOT PLUS CO., LTD. appears in FDA device records in Suzhou Jiangsu, CN. 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 Endoclot Plus Co., Ltd. between 2017 and 2021. The busiest year on record is 2017, with 1. The most recent is 2021, with 1.

Clearances by year, as a table
510(k) clearance decisions for Endoclot Plus Co., Ltd., by decision year
YearClearances
20171
20201
20211
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K190677EndoClotQAUSubstantially Equivalent
K191254EndoClotPLLSubstantially Equivalent
K162197EndoClotGCJSubstantially Equivalent

Registered establishments

FDA registered establishments for Endoclot Plus Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30131557683013155768ENDOCLOT PLUS CO., LTD.Unit 101, B8 Building, 218 Xinghu Street, Suzhou Jiangsu 215000 CN2026

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