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SureCath Set 28028S

by Coloplast A/S

SureCath Set 28028S is a Class II device made by Coloplast A/S, cleared under FDA 510(k) K973070 on 6 Nov 1997 and listed in FDA GUDID since 2 Sep 2016 (UDI-DI 05708932021128), 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) K973070

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 Number05708932021128 UDI-DI Date2 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK973070 Date6 Nov 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K973070 decided 6 Nov 1997 Active
  • FDA GUDID UDI-DI 05708932021128 listed 2 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K973070
  2. Listed FDA GUDID 05708932021128

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SureCath Set
Generic name
Single-administration urethral catheterization kit, single-use
Model / Ref / Catalog
28028S
Primary DI / UDI-DI
05708932021128
FDA product code
EZD
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 Gauge — 14 French
Catheter Working Length — 13.4 Inch
Catheter Working Length — 34 Centimeter

Related devices

Category: Single-administration urethral catheterization kit, single-use

Cleared under the same submission (K973070)

and 7 more cleared under K973070

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)