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Ultrasonic Bipolar Generator Usg-410

by Olympus Medical Systems Corporation GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 26 Oct 2026

Recall ongoing. 4 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04953170442353 UDI-DIDate4 Dec 2025ListedStatusIn distribution

Coverage

1 jurisdiction

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 America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

4 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-1854-2026 FDA Class II initiated 23 Mar 2026
    • Ongoing Z-1851-2026 FDA Class II initiated 23 Mar 2026
    • Ongoing Z-1853-2026 FDA Class II initiated 23 Mar 2026
    • Ongoing Z-1852-2026 FDA Class II initiated 23 Mar 2026

    Potential for detachment of a distal tip component of the device during use.

Specification

GUDID

Trade Name
Ultrasonic Bipolar Generator
Generic Name
Electrosurgical/ultrasonic surgical system generator
Model / Ref / Catalog
USG-410, N6192440
Description
"This product is Version 2. A Version 1 product with the same name exists."
Primary DI / UDI-DI
04953170442353
510(k) Number
FDA Product Code
GEI, LFL
GMDN Term
Electrosurgical/ultrasonic surgical system generator
Regulation Number
878.4400
Commercial Distribution
In Commercial Distribution

Related devices

Cleared under the same submission (K252150)

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →