Supercath 5— 510(k) K190001

Name: FDA 510(k) clearance K190001
Creator: U.S. Food and Drug Administration
Published: 2019-09-20

Substantially Equivalent

Togo Medikit Co., Ltd.

FDA 510(k) clearance K190001 for Supercath 5, Substantially Equivalent on 2019-09-20. Applicant: Togo Medikit Co., Ltd.. Device class: 2.

Clearance details

Applicant: Togo Medikit Co., Ltd.
Product code: Code FOZ
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 2019-01-02
Decision date: 2019-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hyuga City, JP

Download summary PDF View on FDA.gov ↗

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K200379 — Super Sheath2020-03-19
K172496 — SUPERCATH 5 (26G)2018-03-23
K160592 — SUPERCATH 62016-08-12
K141070 — SUPER SHEATH2015-01-15

Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.