510(k) K262570

Device

TZ Medical Birthing Balloon Kit

Applicant

TZ Medical

510(k) number

K262570

Product code

PFJ

Decision

Substantially Equivalent (SESE)

Decision date

2026-10-29

Date received

2026-07-24

Regulation

884.4260

Classification name

Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor

Medical specialty

Obstetrics/Gynecology

Review panel

Obstetrics/Gynecology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N