PUMA-G Pediatric System— 510(k) K242211

Substantially Equivalent

Coaptech, Inc.

FDA 510(k) clearance K242211 for PUMA-G Pediatric System, Substantially Equivalent on 2025-04-29. Applicant: Coaptech, Inc..

Clearance details

Applicant: Coaptech, Inc.
Product code: Code KGC
Advisory panel: Gastroenterology, Urology
Date received: 2024-07-29
Decision date: 2025-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KGC

product code KGC

Death: 7
Total: 7

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.