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Mediplus 2385

by Mediplus, Ltd.

Mediplus 2385 is a Class II device made by Mediplus, Ltd., cleared under FDA 510(k) K031617 on 16 Jan 2004 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05055140700858), active as of 22 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 22 Oct 2026

Documents

510(k) K031617

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05055140700858 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK031617 Date16 Jan 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K031617 decided 16 Jan 2004 Active
  • FDA GUDID UDI-DI 05055140700858 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K031617
  2. Listed FDA GUDID 05055140700858

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mediplus
Generic name
Gastrointestinal motility manometric catheter, non-electronic
Model / reference
2385
Primary DI / UDI-DI
05055140700858
510(k) Number
FDA product code
KLA
GMDN term
Gastrointestinal motility manometric catheter, non-electronic
Device class
Class II
Regulation number
876.1725
GUDID distribution status
In Commercial Distribution
Size
Length — 150.0 Centimeter
Outer Diameter — 3.9 Millimeter

Related devices

Category: Gastrointestinal motility manometric catheter, non-electronic

Cleared under the same submission (K031617)

Similar devices

Other devices filed under FDA product code KLA (MONITOR, ESOPHAGEAL MOTILITY, AND TUBE).

Other devices from Mediplus, Ltd.

See all devices from Mediplus, Ltd. →

Properties

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