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Morganstern Prostate Stabilization and Seeding Kit

by Medical Device Technologies, Inc.

510(k) K944522

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 NumberK944522 Date24 Feb 1995ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2022-2010 FDA Unclassified (pre-2012) initiated 1 Sep 2009

    Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast Localization Needles, Soft Tissue Biopsy Needles, Vascular Access Needles, Bone Biopsy Needles, Access Needles, Galactography Kit, Stabilization Needles and Needle Guides for packaging integrity.

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  • Withdrawn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
IWJ
Device Class
Class I
Regulation
21 CFR Part 892.5650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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