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SpeediCath Flex Set 28946

by Coloplast A/S 2 variants

SpeediCath Flex Set 28946 is a Class II device made by Coloplast A/S, cleared under FDA 510(k) K222059 on 21 Sep 2022 and listed in FDA GUDID since 5 Feb 2026 (UDI-DI 05708932778138), 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) K222059

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 Number05708932778138 UDI-DI Date5 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK222059 Date21 Sep 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K222059 decided 21 Sep 2022 Active
  • FDA GUDID UDI-DI 05708932778138 listed 5 Feb 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K222059
  2. Listed FDA GUDID 05708932778138

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SpeediCath Flex Set
Generic name
Single-administration urethral catheterization kit, single-use
Model / Ref / Catalog
28946
Primary DI / UDI-DI
05708932778138
510(k) Number
FDA product code
EZD, FCM
GMDN term
Single-administration urethral catheterization kit, single-use
Device class
Class II
Regulation number
876.5130
GUDID distribution status
In Commercial Distribution
Size
Catheter Working Length — 13 Inch
Catheter Gauge — 16 French
Catheter Working Length — 33 Centimeter

Related devices

Cleared under the same submission (K222059)

and 6 more cleared under K222059

Similar devices

Other devices filed under FDA product code EZD (Catheter, straight).

Other devices from Coloplast A/S

See all devices from Coloplast A/S →

Properties

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