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Rapid Strand Rx

by Oncura, Inc.

510(k) K063177

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK063177 Date30 Nov 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0266-2012 FDA Unclassified (pre-2012) initiated 20 Sep 2011

    There is a potential brachytherapy over or under dose with the RAPID Strand Rx kit that may impact patient therapy.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KXK
Device Class
Class II
Regulation
21 CFR Part 892.5730
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent