Skip to content

BioZorb Marker GOLD / LP Marker GOLD

by Focal Therapeutics 510(k)

Active United States

510(k) K171467

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK171467 Date9 Nov 2017ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
IYE
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Focal Therapeutics

  • BioZorb SP Marker

    Class II

  • BioZorb LP Marker Open recall

    Class II

  • BioZorb Marker Open recall

    Class II

  • Tissue Marker

    Class II