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Single Use Electrosurgical Knife KD-625 KD-625LR

by Olympus Medical Systems Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

3 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 Number04953170407826 UDI-DI Date21 May 2019ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1547-2024 FDA Class II initiated 1 Mar 2024
    • Ongoing Z-1548-2024 FDA Class II initiated 1 Mar 2024

    Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifications regarding electrosurgical unit compatibility and output due to reports of serious injury

    • Ongoing Z-1223-2026 FDA Class II initiated 17 Feb 2024

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

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  • Withdrawn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-625
Generic Name
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Model / Reference
KD-625LR
Primary DI / UDI-DI
04953170407826
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 (K182408)

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 (9)

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