510(k) clearance

TZ Medical Birthing Balloon Kit

FDA 510(k) source

510(k) number

K262570

Applicant

TZ Medical

Decision date

Oct 29, 2026

Date received

Jul 24, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

PFJ

Device type

Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor

Device class

Class II

Regulation

21 CFR 884.4260

Advisory committee

Obstetrics/Gynecology

Statement or summary

Summary

Third party

N

Location

Tualatin, OR, US