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TRANSDISCAL SYSTEM - Tda-Ppu-1

by Baylis Medical Co., Inc.

510(k) K062937

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 NumberK062937 Date8 Jan 2007ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1755-2010 FDA Unclassified (pre-2012) initiated 12 May 2010

    Name of the device reflected on the product packing sleeve is incorrect.

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  • Withdrawn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
GXI
Models / Variants
Tda-Ppu-1
Device Class
Class II
Regulation
21 CFR Part 882.4725
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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