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Ul-DU500R

by Zimmer Orthopaedic Surgical Products

Ul-DU500R is a Class II device made by Zimmer Orthopaedic Surgical Products, cleared under FDA 510(k) K133786 on 21 Mar 2014 (1 earlier submission) and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00889024465824), 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

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024465824 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK133786 Date21 Mar 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K133786 decided 21 Mar 2014 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00889024465824 listed 22 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K123188
  2. Cleared FDA 510(k) K133786
  3. Listed FDA GUDID 00889024465824

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Surgical fluid/smoke waste management system suction unit
Model / Ref / Catalog
UL-DU500R
Primary DI / UDI-DI
00889024465824
510(k) Number
FDA product code
JCX
GMDN term
Surgical fluid/smoke waste management system suction unit
Device class
Class II
Regulation number
878.4780
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical fluid/smoke waste management system suction unit

Cleared under the same submission (K123188)

and 2 more cleared under K123188

Cleared under the same submission (K133786)

and 2 more cleared under K133786

Similar devices

Other devices filed under FDA product code JCX (APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED).

Other devices from Zimmer Orthopaedic Surgical Products

See all devices from Zimmer Orthopaedic Surgical Products →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)