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Disposable Emr Kit K-003

by Olympus Medical Systems Corporation

Disposable Emr Kit K-003 is a Class II device made by Olympus Medical Systems Corporation, listed in FDA GUDID since 21 Sep 2018 (UDI-DI 04953170048586), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04953170048586 UDI-DI Date21 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Disposable Emr Kit
Generic name
Endoscopic electrosurgical submucosal lift/resection set
Model / reference
K-003
Primary DI / UDI-DI
04953170048586
FDA product code
FDS
GMDN term
Endoscopic electrosurgical submucosal lift/resection set
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscopic electrosurgical submucosal lift/resection set

Similar devices

Other devices filed under FDA product code FDS (Gastroscope and accessories, flexible/rigid).

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)