Skip to content

Solo Scope Colonoscope System

by Gi View Ltd.

510(k) K261015

Solo Scope Colonoscope System is a Class II device made by Gi View Ltd., cleared under FDA 510(k) K261015 on 21 Aug 2026, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK261015 Date21 Aug 2026ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
FDF
FDA applicant
Gi View, Ltd.
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Devices cleared under K261015

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K261015
UDI-DISize and differences
SOLO SCOPE Disposable Colonoscope 1
Gi View, Ltd.
MPK02151 / 117290016992158
Single use: yes
On the market
SOLO SCOPE Video Controller 1
Gi View, Ltd.
MPK02157 / 117290016992172
Single use: no
On the market

Similar devices

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