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Ultra-Pro e™ Variable Angle Needle Guide 610-1089, 610-1220

by Civco Medical Instruments Co., Inc. EUDAMEDGUDID

Active European Union and United States

Ref 610-1089

Regulatory status

as of 28 Oct 2026

Recall ongoing on a related submission. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0841436101TD101C2NF Basic UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10841436102008 UDI-DIDate22 Aug 2017ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

7 recalls · 1 ongoing · FDA

    • Ongoing Z-1892-2025 FDA Class II initiated 1 May 2025 via K093713, on the same 510(k)

    During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.

    • Terminated Z-2888-2018 FDA Class II initiated 23 Feb 2018 via K093713, on the same 510(k)

    A cover failed leak testing during validation testing of new needle guides from a replacement tool.

  • 5 recalls, same reason

    • Terminated Z-0286-2016 FDA Class II initiated 21 Oct 2015 via K093713, on the same 510(k)
    • Terminated Z-0288-2016 FDA Class II initiated 21 Oct 2015 via K093713, on the same 510(k)
    • Terminated Z-0289-2016 FDA Class II initiated 21 Oct 2015 via K093713, on the same 510(k)
    • Terminated Z-0290-2016 FDA Class II initiated 21 Oct 2015 via K093713, on the same 510(k)
    • Terminated Z-0287-2016 FDA Class II initiated 21 Oct 2015 via K093713, on the same 510(k)

    Sterility of the product cannot be assured.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · GUDID

Trade Name
Ultra-Pro e™ Variable Angle Needle Guide
Generic Name
Needle guide, single-use
Device Name
General Purpose Guidance – In-Plane, Open Channel (ultra pro E guide)
Model / Ref / Catalog
610-1089, 610-1220
Primary DI / UDI-DI
10841436102008
Basic UDI-DI
0841436101TD101C2NF
510(k) Number
FDA Product Code
IYO
EMDN Code
A018002 Needle guides
GMDN Term
Needle guide, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1560
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution
Sterilization Method
Ethylene Oxide
Size
Length — 1.6 Inch
Height — 1.3 Inch

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
610-1089
GUDID
610-1089, 610-1220
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Needle guide, single-use

Cleared under the same submission (K093713)

Show all (12)

Other devices from Civco Medical Instruments Co., Inc.

See all devices from Civco Medical Instruments Co., Inc. →

Properties

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

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No