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

HYUGA CITY Miyazaki, JP

TOGO MEDIKIT CO., LTD. appears in FDA device records in HYUGA CITY Miyazaki, JP. FDA records list 17 510(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
17
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 17 510(k) clearances for Togo Medikit Co., Ltd. between 1986 and 2024. The busiest year on record is 2006, with 3. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Togo Medikit Co., Ltd., by decision year
YearClearances
19862
20051
20063
20092
20122
20141
20151
20161
20181
20191
20201
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K241230Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008DYBSubstantially Equivalent
K200379Super SheathDRESubstantially Equivalent
K190001Supercath 5FOZSubstantially Equivalent
K172496SUPERCATH 5 (26G)FOZSubstantially Equivalent
K160592SUPERCATH 6FOZSubstantially Equivalent
K141070SUPER SHEATHDRESubstantially Equivalent
K140419SUPERCATH5FOZSubstantially Equivalent
K121504SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETSDYBSubstantially Equivalent
K112290SUPERCATH Z3VFOZSubstantially Equivalent
K093546SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XXFOZSubstantially Equivalent
K081953SUPERCATH 5FOZSubstantially Equivalent
K052267SUPERCATH VFIESubstantially Equivalent
K060190SUPER SHEATH XL INTRODUCER SHEATHDYBSubstantially Equivalent
K052557SUPER SHEATH INTRODUCER SHEATHDRESubstantially Equivalent
K050114SUPERCATH Z3VFOZSubstantially Equivalent
K864038SUPERCATH I.V. CATHETERFOZSubstantially Equivalent
K854773SUPERCATH A.V. FISTULAFIESubstantially Equivalent

Registered establishments

FDA registered establishments for Togo Medikit Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96121263002807548TOGO MEDIKIT CO., LTD.17148-6 AZA KAMEKAWA, HYUGA CITY Miyazaki 883-0062 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

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