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Elmed ST310703939

by Elmed Incorporated

Elmed ST310703939 is a robotic surgical system application software (FDA Class I; FDA product code KOA, Surgical Instruments, G-U, Manual (And Accessories)) made by Elmed Incorporated, listed in FDA GUDID since 24 Apr 2024 (UDI-DI 00198506001659), 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 Number00198506001659 UDI-DI Date24 Apr 2024ListedStatusListed 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  • Withdrawn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
Elmed
Generic name
Robotic surgical system application software
Model / Ref / Catalog
ST310703939
Description
GUYON Catheter Guide GUYON cm, 15-1/2"
Primary DI / UDI-DI
00198506001659
FDA product code
KOA
GMDN term
Robotic surgical system application software
Device class
Class I
Regulation number
876.4730
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Robotic surgical system application software

Similar devices

Other devices filed under FDA product code KOA (Surgical Instruments, G-U, Manual (And Accessories)).

Other devices from Elmed Incorporated

See all devices from Elmed Incorporated →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)