Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PUMA-G Pediatric System

K-Number: K242211 · 2025-04-29

ApplicantCoaptech, Inc.
Decision Date2025-04-29
Product CodeKGC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PUMA-G Pediatric 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 2025-04-29 under 510(k) number K242211. 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 Pediatric System?

PUMA-G Pediatric System is a medical device that received FDA 510(k) clearance on 2025-04-29. The listed applicant is Coaptech, Inc.. The 510(k) number is K242211.

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

PUMA-G Pediatric System received FDA 510(k) clearance on 2025-04-29, under 510(k) number K242211.

Who is the listed applicant for PUMA-G Pediatric 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 Pediatric System?

The FDA product code for PUMA-G Pediatric 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.

K223916PUMA-G 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.

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 IncorporatedK183057PUMA-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.

↑