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SOLO SCOPE Video Controller 1

by Gi View, Ltd.

SOLO SCOPE Video Controller 1 (MPK02157) is a Class II device made by Gi View, Ltd., cleared under FDA 510(k) K261015 on 21 Aug 2026 and listed in FDA GUDID since 25 Aug 2026 (UDI-DI 17290016992172), 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

510(k) K261015

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number17290016992172 UDI-DI Date25 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK261015 Date21 Aug 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K261015 decided 21 Aug 2026 Active
  • FDA GUDID UDI-DI 17290016992172 listed 25 Aug 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K261015
  2. Listed FDA GUDID 17290016992172

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SOLO SCOPE Video Controller
Generic name
Flexible video colonoscope, single-use
Model / Ref / Catalog
1, MPK02157
Primary DI / UDI-DI
17290016992172
510(k) Number
FDA product code
FDF, FET
GMDN term
Flexible video colonoscope, single-use
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Cleared under the same submission (K261015)

Similar devices

Other devices filed under FDA product code FDF (Colonoscope And Accessories, Flexible/Rigid).

Other devices from Gi View, Ltd.

See all devices from Gi View, Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)