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FDA 510(k)

PUMA-G System

K-Number: K183057 · 2019-04-10

ApplicantCoaptech, LLC
Decision Date2019-04-10
Product CodeKGC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PUMA-G System is the device name listed in this FDA 510(k) record. The listed applicant is Coaptech, LLC. It received FDA 510(k) clearance on 2019-04-10 under 510(k) number K183057. The device is classified under product code KGC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PUMA-G System?

PUMA-G System is a medical device that received FDA 510(k) clearance on 2019-04-10. The listed applicant is Coaptech, LLC. The 510(k) number is K183057.

When did PUMA-G System receive FDA 510(k) clearance?

PUMA-G System received FDA 510(k) clearance on 2019-04-10, under 510(k) number K183057.

Who is the listed applicant for PUMA-G System?

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

What is the FDA product code for PUMA-G System?

The FDA product code for PUMA-G System is KGC.

Related Clinical Trials

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.

NCT05966311Pediatric Percutaneous Ultrasound Gastrostomy TechniqueRECRUITING

Other records listing Coaptech, LLC as applicant

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 SystemK223916PUMA-G System

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.K182832Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor SetCook IncorporatedK170323Entuit 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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