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FDA 510(k)

Fidmi Low Profile Enteral Feeding Device

K-Number: K191844 · 2019-09-30

ApplicantFidmi Medical, Ltd.
Decision Date2019-09-30
Product CodeKGC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Fidmi Low Profile Enteral Feeding Device is the device name listed in this FDA 510(k) record. The listed applicant is Fidmi Medical, Ltd.. It received FDA 510(k) clearance on 2019-09-30 under 510(k) number K191844. 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 Fidmi Low Profile Enteral Feeding Device?

Fidmi Low Profile Enteral Feeding Device is a medical device that received FDA 510(k) clearance on 2019-09-30. The listed applicant is Fidmi Medical, Ltd.. The 510(k) number is K191844.

When did Fidmi Low Profile Enteral Feeding Device receive FDA 510(k) clearance?

Fidmi Low Profile Enteral Feeding Device received FDA 510(k) clearance on 2019-09-30, under 510(k) number K191844.

Who is the listed applicant for Fidmi Low Profile Enteral Feeding Device?

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

What is the FDA product code for Fidmi Low Profile Enteral Feeding Device?

The FDA product code for Fidmi Low Profile Enteral Feeding Device is KGC.

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.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.

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