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Vision1 VIS101

by Black Diamond Video, Inc.

Vision1 VIS101 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 00724995209186), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK231878 Date25 Jul 2023DecidedStatusActive
United StatesGUDID listing Number00724995209186 UDI-DI Date10 Jun 2022ListedStatusListed GUDID: in commercial distribution

Official records

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 00724995209186 listed 10 Jun 2022 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K211347
  2. Listed FDA GUDID 00724995209186
  3. Cleared FDA 510(k) K223466
  4. Cleared FDA 510(k) K231878

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vision1
Generic name
Endoscopic video image display unit
Model / Ref / Catalog
VIS101
Primary DI / UDI-DI
00724995209186
510(k) Number
FDA product code
FGB
GMDN term
Endoscopic video image display unit
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
Size
Width — 3 Centimeter
Length — 230 Centimeter
Outer Diameter — 2.4 Millimeter

Related devices

Category: Endoscopic video image display unit

Cleared under the same submission (K211347)

Cleared under the same submission (K223466)

Similar devices

Other devices filed under FDA product code FGB (Ureteroscope and accessories, flexible/rigid).

Other devices from Black Diamond Video, Inc.

See all devices from Black Diamond Video, Inc. →

Properties

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