K093079

Substantially Equivalent

TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U

Applicant: Hobbs Medical, Inc.
Product code: KNS
Advisory panel: Gastroenterology, Urology
Date received: 2009-09-30
Decision date: 2010-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stafford Springs, CT, US

Adverse events under product code KNS

product code KNS

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.