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Single Use Electrosurgical Knife KD-620QR

by Olympus Medical Systems Corporation EUDAMEDGUDID

Active European Union Open recall

Ref N3046030

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04953170251504 Basic UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170251504 UDI-DIDate21 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD 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

9 recalls · 1 ongoing · FDA

    • Ongoing Z-1222-2026 FDA Class II initiated 17 Feb 2024

    A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

  • 8 recalls, same reason

    • Terminated Z-0978-2021 FDA Class II initiated 4 Jan 2021
    • Terminated Z-0980-2021 FDA Class II initiated 4 Jan 2021
    • Terminated Z-0975-2021 FDA Class II initiated 4 Jan 2021
    • Terminated Z-0981-2021 FDA Class II initiated 4 Jan 2021
    • Terminated Z-0979-2021 FDA Class II initiated 4 Jan 2021
    • Terminated Z-0976-2021 FDA Class II initiated 4 Jan 2021
    • Terminated Z-0977-2021 FDA Class II initiated 4 Jan 2021
    • Terminated Z-0974-2021 FDA Class II initiated 4 Jan 2021

    Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Specification

EUDAMED · GUDID

Trade Name
Single Use Electrosurgical Knife KD-620QR EUDAMED
Single Use Electrosurgical Knife GUDID
Generic Name
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Model / Reference
N3046030 EUDAMED
KD-620QR GUDID
Primary DI / UDI-DI
04953170251504
Basic UDI-DI
B-04953170251504
FDA Product Code
KNS
EMDN Code
K02010199 Mono- and bipolar instruments, single-use - other
GMDN Term
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.4300
Market of Registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
N3046030
GUDID
KD-620QR
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K092309)

Show all (12)

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

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

Other properties (19)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No