Pure Vu System— 510(k) K191220

Clearance details

Applicant

Motus GI Medical Technologies , Ltd.

Product code

Code FDF

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2019-05-07

Decision date

2019-06-06

Decision

Substantially Equivalent

Clearance type

Special

Location

Tirat Carmel, IL

• K261015 — Solo Scope Colonoscope System2026-08-21
• K261587 — Insufflation Retention Device (IRD) (11173-325-101)2026-07-02
• K260423 — Disposable Endoscopic Distal Attachments2026-05-28
• K252457 — Disposable Distal End Tape Hood2026-01-30
• K244029 — ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)2025-09-24

• K232922 — Pure-Vu EVS System2023-10-20
• K220007 — Pure-Vu EVS System2022-02-10
• K210981 — Pure Vu System2021-04-29
• K181437 — Pure Vu System2018-06-21
• K173392 — Pure-Vu System2017-12-12

Death

8

Injury

729

Malfunction

61,773

Total

62,510

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →