510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K262151Substantially Equivalent

SpaceOAR Flex™ System

Boston Scientific Corporation, Marlborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(78 days to decision)
Product code
OVB Hydrogel Spacer
Regulation
21 CFR 892.5725
Device class
Class II
Review panel
Radiology
Applicant
Boston Scientific Corporation Urology, Marlborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OVB

Trailing 12 months
2 clearances under product code OVB in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OVB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260