Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15

by Fuji Dynamics, Ltd. 510(k)

Active United States

510(k) K161055

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK161055	Date12 Jul 2016Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 26 Oct 2026.

Specification

510(k)

510(k) Number: K161055
FDA Product Code: KPI
Models / Variants: Fuji – 01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
FDA applicant: Fuji Dynamics , Ltd.

Device Class: Class II
Regulation: 21 CFR Part 876.5320
Advisory Committee: Gastroenterology, Urology
FDA Decision: SESE Substantially Equivalent

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