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Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter

by Cook Incorporated

510(k) K172051

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 26 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK172051 Date10 Jan 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 Oct 2026.

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  • Withdrawn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
MQF
Device Class
Class II
Regulation
21 CFR Part 884.6110
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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