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Single Use Electrosurgical Knife KD-650 KD-650U

by Olympus Medical Systems Corporation 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04953170453991 UDI-DI Date29 Apr 2023ListedStatusListed GUDID: in commercial distribution

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

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Single Use Electrosurgical Knife KD-650
Generic Name
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Model / Ref / Catalog
KD-650U, N3498940
Primary DI / UDI-DI
04953170453991
FDA Product Code
KNS
GMDN Term
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Device Class
Class II
Regulation Number
876.4300
GUDID distribution status
In Commercial Distribution

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
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

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