Uretero1 URORD101

by Black Diamond Video, Inc.

Uretero1 URORD101 is a Class II device made by Black Diamond Video, Inc., cleared under FDA 510(k) K231878 on 25 Jul 2023 (2 earlier submissions) and listed in FDA GUDID since 10 Jun 2022 (UDI-DI 00724995209179), active as of 23 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 23 Oct 2026

Documents

+2 more

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK231878	Date25 Jul 2023Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK223466	Date17 Feb 2023Decided	StatusActive
United States	GUDID listing	Number00724995209179 UDI-DI	Date10 Jun 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK211347	Date23 Nov 2021Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00724995209179
FDA 510(k) database 510(k) number K231878
FDA 510(k) database 510(k) number K223466
FDA 510(k) database 510(k) number K211347

Across registries

2 registries list this device

FDA 510(k) K231878 decided 25 Jul 2023 Active· +2 more in the status table
FDA GUDID UDI-DI 00724995209179 listed 10 Jun 2022 Listed

Timeline

4 dated events

23 Nov 2021 Cleared FDA 510(k) K211347
10 Jun 2022 Listed FDA GUDID 00724995209179
17 Feb 2023 Cleared FDA 510(k) K223466
25 Jul 2023 Cleared FDA 510(k) K231878

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Uretero1
Generic name: Flexible video ureteroscope, single-use
Model / Ref / Catalog: URORD101

Primary DI / UDI-DI: 00724995209179
510(k) Number: K211347
K223466
K231878
FDA product code: FGB
GMDN term: Flexible video ureteroscope, single-use

Device class: Class II
Regulation number: 876.1500
GUDID distribution status: In Commercial Distribution

Size: Outer Diameter — 2.4 Millimeter
Length — 230 Centimeter
Width — 3 Centimeter

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Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (9, all answered No)