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Single Use Electrosurgical Knife KD-650 KD-650U

by Olympus Medical Systems Corporation

Ref N3498930

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04953170265785 Basic UDI-DI 04953170265785UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170265785 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Single Use Electrosurgical Knife KD-650 KD-650U EUDAMED
Single Use Electrosurgical Knife KD-650 GUDID
Generic Name
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Device Name
Single Use Electrosurgical Knife
Model / Reference
N3498930 EUDAMED
KD-650U GUDID
Primary DI / UDI-DI
04953170265785
Basic UDI-DI
B-04953170265785
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
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
N3498930
GUDID
KD-650U
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

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