Creo Electrosurgical System with HS1 Hemostasis Accessory— 510(k) K192905

Clearance details

Applicant

Creo Medical, Ltd.

Product code

Code KNS

Device class

Class 2

Regulation

21 CFR 876.4300

Advisory panel

Gastroenterology, Urology

Date received

2019-10-15

Decision date

2020-03-19

Decision

Unknown

Clearance type

Traditional

Location

Chepstow, GB

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Death

44

Injury

2,361

Malfunction

4,771

Total

7,176

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 →