TZ Medical Birthing Balloon Kit— 510(k) K262570
Substantially EquivalentTZ Medical
FDA 510(k) clearance K262570 for TZ Medical Birthing Balloon Kit, Substantially Equivalent on 2026-10-29. Applicant: TZ Medical. Device class: 2.
Clearance details
- Applicant
- TZ Medical
- Product code
- Product code PFJ
- Device class
- Class 2
- Regulation
- 21 CFR 884.4260
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tualatin, OR, US
Recent devices under product code PFJ
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