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ESG-400 Footswitch Double Pedal, Footswitch Single Pedal, P-Cord

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K141225Ref WA91301WRef WB50402WRef WB950243

by Olympus Winter & Ibe GmbH

Identity

Trade Name
Foot switch double pedal EUDAMED
Foot switch, double pedal EUDAMED
Footswitch ESG EUDAMED
Olympus FDA UDI
Generic Name
Foot-switch, electrical FDA UDI
Device Name
Footswitches - wired EUDAMED
Model / Reference
WA91301W EUDAMEDFDA UDI
WB950243 EUDAMEDFDA UDI
WB50402W EUDAMEDFDA UDI

Identifiers

Catalog Number
WA91301W FDA UDI
WB950243 FDA UDI
WB50402W FDA UDI
Primary DI / UDI-DI
04042761085946 EUDAMEDFDA UDI
04042768502439 EUDAMEDFDA UDI
04042761076807 EUDAMEDFDA UDI
Basic UDI-DI
4042761110194Z EUDAMED
510(k) Number
K141225 FDA 510(k)
K203277 FDA UDI
FDA Product Code
GEI FDA 510(k)FDA UDI
FEQ FDA UDI
EMDN Code
Z12010905 RADIOSURGICAL UNITS EUDAMED
GMDN Term
Foot-switch, electrical FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)FDA UDI
876.1500 FDA UDI
Market of Registration
Germany EUDAMED
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDIFDA UDI

Serial Number

Yes

FDA UDIFDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDIFDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

The ESG-400 is a foot-controlled surgical device designed for use in operating rooms, enabling hands-free activation of endoscopic systems. It features dual-pedal and single-pedal configurations to control irrigation, suction, or other endoscopic functions with precision, enhancing surgeon ergonomics during procedures.

Supplied as a reusable device, the ESG-400 is intended for use in sterile surgical environments and must be properly cleaned and maintained between procedures. It is classified under product code GEI and has received FDA 510(k) clearance and MDR authorization. The device includes a P-Cord for connectivity and is manufactured by Olympus Winter & Ibe GmbH.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Olympus Winter & Ibe GmbH

Sources (7)

  • FDA 510(k) K141225 24 fields · synced Sep 18, 2026
  • FDA UDI f3e977d3-4a9b-433a-9d22-78e743cc0d34 35 fields · synced May 30, 2026
  • FDA UDI 094f231f-f4c9-451a-8f31-db109e51ace5 34 fields · synced May 30, 2026
  • FDA UDI ecd53ba9-1762-4728-b184-cd996ae384e3 34 fields · synced May 30, 2026
  • EUDAMED a6d8e761-aee2-48e0-b3ca-b0b76da4c2c1 61 fields · synced Jul 8, 2026
  • EUDAMED 60fcf686-88fb-4a5f-9a91-e8ac867eb3f5 61 fields · synced Jul 17, 2026
  • EUDAMED aad27e43-d3d6-467d-8165-49b40d63b2d1 61 fields · synced Jul 27, 2026