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FDA 510(k)

Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set

K-Number: K182832 · 2019-06-26

ApplicantCook Incorporated
Decision Date2019-06-26
Product CodeKGC
Advisory CommitteeGU
DecisionUnknown

Device Summary

Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2019-06-26 under approval number K182832. The device is classified under product code KGC. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set?

Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set is a medical device that received FDA 510(k) clearance on 2019-06-26. It is manufactured by Cook Incorporated. The 510(k) number is K182832.

When was Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set approved by the FDA?

Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set received FDA 510(k) clearance on 2019-06-26, under approval number K182832.

What company makes Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set?

Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set is manufactured by Cook Incorporated.

What is the FDA product code for Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set?

The FDA product code for Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set is KGC.

Related Clinical Trials

NCT07234188 POM vs HFNC for Hypoxemia Prevention in Children COMPLETED NCT04647578 Physical Fitness Levels in Children and Adolescents With Chronic Inflammatory Bowel Disease (CIBD): Crohn's Disease, Ulcerative Colitis, Chronic Unclassified Colitis COMPLETED

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

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Related Devices (Code: KGC)

K170323Entuit Start Initial Placement Gastrostomy SetCook Incorporated K191844Fidmi Low Profile Enteral Feeding DeviceFidmi Medical, Ltd. K183057PUMA-G SystemCoaptech, LLC K193612AMT Suture Delivery SystemApplied Medical Technology, Inc. K223916PUMA-G SystemCoaptech, Inc. K242211PUMA-G Pediatric SystemCoaptech, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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