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MONARCH™Guided Percutaneous Access Kit MUR-000012

by Auris Health, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

Recall on shared 510(k) K213334; other models may be affected

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10810068811060 UDI-DI Date4 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0052-2025 FDA Class II initiated 2 Aug 2024 on shared 510(k) K213334

    Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MONARCH™Guided Percutaneous Access Kit
Generic Name
Nephrostomy catheter introduction needle
Model / Ref / Catalog
MUR-000012
Primary DI / UDI-DI
10810068811060
510(k) Number
FDA Product Code
GCB
GMDN Term
Nephrostomy catheter introduction needle
Device Class
Class I
Regulation Number
878.4200
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K213334)

Other devices from Auris Health, Inc.

See all devices from Auris Health, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No