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FDA 510(k)

PUMA-G System

K-Number: K223916 · 2023-03-29

ApplicantCoaptech, Inc.
Decision Date2023-03-29
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, Inc.. It received FDA 510(k) clearance on 2023-03-29 under 510(k) number K223916. 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 2023-03-29. The listed applicant is Coaptech, Inc.. The 510(k) number is K223916.

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

PUMA-G System received FDA 510(k) clearance on 2023-03-29, under 510(k) number K223916.

Who is the listed applicant for PUMA-G System?

The FDA 510(k) record lists Coaptech, Inc. 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, Inc. 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 SystemK183057PUMA-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.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 IncorporatedK183057PUMA-G SystemCoaptech, LLCK170323Entuit Start Initial Placement Gastrostomy SetCook Incorporated

Official Source

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

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