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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 the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2019-06-26 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K182832.

When did Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set receive FDA 510(k) clearance?

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

Who is the listed applicant for Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: KGC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242211PUMA-G Pediatric SystemCoaptech, Inc.K223916PUMA-G SystemCoaptech, Inc.K193612AMT Suture Delivery SystemApplied Medical Technology, Inc.K191844Fidmi Low Profile Enteral Feeding DeviceFidmi Medical, Ltd.K183057PUMA-G SystemCoaptech, LLCK170323Entuit Start Initial Placement Gastrostomy SetCook Incorporated

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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