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SureCath 28037

by Coloplast A/S 2 variants

SureCath 28037 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 05708932021500), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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 Number05708932021500 UDI-DI Date2 Sep 2016ListedStatusListed GUDID: not 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 05708932021500 listed 2 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K973070
  2. Listed FDA GUDID 05708932021500

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SureCath
Generic name
Single-administration urethral catheterization kit, single-use
Model / Ref / Catalog
28037
Primary DI / UDI-DI
05708932021500
510(k) Number
FDA product code
EZD
GMDN term
Single-administration urethral catheterization kit, single-use
Device class
Class II
Regulation number
876.5130
GUDID distribution status
Not in Commercial Distribution
Size
Catheter Gauge — 16 French
Length — 40 Centimeter
Outer Diameter — 5.3 Millimeter
Total Volume — 1200 Milliliter

Related devices

Cleared under the same submission (K973070)

and 8 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)