Skip to content

Concept Esa-5190

by Conmed Corporation 2 variants

Concept Esa-5190 is a Class II device made by Conmed Corporation, cleared under FDA 510(k) K983652 on 23 Mar 1999 and listed in FDA GUDID since 24 Mar 2026 (UDI-DI 10845854035597), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K983652

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10845854035597 UDI-DI Date24 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK983652 Date23 Mar 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K983652 decided 23 Mar 1999 Active
  • FDA GUDID UDI-DI 10845854035597 listed 24 Mar 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K983652
  2. Listed FDA GUDID 10845854035597

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Concept
Generic name
Endoscopic electrosurgical electrode, monopolar, single-use
Model / Ref / Catalog
ESA-5190
Primary DI / UDI-DI
10845854035597
510(k) Number
FDA product code
GEI
GMDN term
Endoscopic electrosurgical electrode, monopolar, single-use
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Size
Angle — 90 degree

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)