PUMA-G Pediatric System— 510(k) K242211

Name: FDA 510(k) clearance K242211
Creator: U.S. Food and Drug Administration
Published: 2025-04-29

Substantially Equivalent

Coaptech, Inc.

FDA 510(k) clearance K242211 for PUMA-G Pediatric System, Substantially Equivalent on 2025-04-29. Applicant: Coaptech, Inc.. Device class: 2.

Clearance details

Applicant: Coaptech, Inc.
Product code: Code KGC
Device class: Class 2
Regulation: 21 CFR 876.5980
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 ↗

Recent devices under product code KGC

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K223916 — PUMA-G System2023-03-29
K193612 — AMT Suture Delivery System2020-03-12
K191844 — Fidmi Low Profile Enteral Feeding Device2019-09-30
K182832 — Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set2019-06-26
K183057 — PUMA-G System2019-04-10

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.