510(k) clearance

SpaceOAR Flex™ System

FDA 510(k) source

510(k) number

K262151

Applicant

Boston Scientific Corporation

Decision date

Sep 11, 2026

Date received

Jun 25, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

OVB

Device type

Hydrogel Spacer

Device class

Class II

Regulation

21 CFR 892.5725

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Marlborough, MA, US