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Tayman Medical, Inc. Stepping & Stabilizing System

by Tayman Medical, Inc.

510(k) K963302

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK963302 Date6 Feb 1997ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0221-2007 FDA Unclassified (pre-2012) initiated 9 Nov 2006

    The In/Out adjustment knob can be over-turned, ultimately causing the incorrect placement of radioactive seeds in the patient.

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  • Withdrawn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
ITX
Device Class
Class II
Regulation
21 CFR Part 892.1570
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Tayman Medical, Inc.

  • Accu Guide

    Class II