Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set— 510(k) K182832

Name: FDA 510(k) clearance K182832
Creator: U.S. Food and Drug Administration
Published: 2019-06-26

Unknown

Cook Incorporated

FDA 510(k) clearance K182832 for Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set, Unknown on 2019-06-26. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant: Cook Incorporated
Product code: Code KGC
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2018-10-09
Decision date: 2019-06-26
Decision: Unknown
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KGC

view all

K242211 — PUMA-G Pediatric System2025-04-29
K223916 — PUMA-G System2023-03-29
K193612 — AMT Suture Delivery System2020-03-12
K191844 — Fidmi Low Profile Enteral Feeding Device2019-09-30
K183057 — PUMA-G System2019-04-10

More clearances from Cook Incorporated

view all

K233177 — Nest VT Vitrification Device2024-03-08
K222254 — Gunther Tulip Vena Cava Filter Retrieval Set2023-05-16
K223098 — Bakri Essential Postpartum Balloon2022-10-28
K210734 — Endovascular Dilator and Sets2021-04-06
K203670 — Extra Large Check-Flo Introducer2021-02-16

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.