SPIKE GUARD— 510(k) K812130

Substantially Equivalent

Clinipad Corp.

FDA 510(k) clearance K812130 for SPIKE GUARD, Substantially Equivalent on 1981-09-09. Applicant: Clinipad Corp..

Clearance details

Applicant: Clinipad Corp.
Product code: Code KDJ
Advisory panel: Gastroenterology, Urology
Date received: 1981-07-27
Decision date: 1981-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDJ

product code KDJ

Death: 298
Injury: 9,221
Malfunction: 8,438
Other: 1
Total: 17,958

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.