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FDA 510(k)

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler

K-Number: K220917 · 2022-05-18

ApplicantGri-Alleset, Inc.
Decision Date2022-05-18
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler is a medical device manufactured by Gri-Alleset, Inc.. It received FDA 510(k) clearance on 2022-05-18 under approval number K220917. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler?

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler is a medical device that received FDA 510(k) clearance on 2022-05-18. It is manufactured by Gri-Alleset, Inc.. The 510(k) number is K220917.

When was gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler approved by the FDA?

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler received FDA 510(k) clearance on 2022-05-18, under approval number K220917.

What company makes gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler?

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler is manufactured by Gri-Alleset, Inc..

What is the FDA product code for gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler?

The FDA product code for gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler is FMK.

Related Clinical Trials

NCT06587282 PREEMIE: Study for Treatment of PDA in Premature Infants ACTIVE_NOT_RECRUITING

Other Devices by Gri-Alleset, Inc.

K210131ComfortGuard Surgical Isolation Gown K210860Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 K242664gentleheel® Adult Incision Device

Related Devices (Code: FMK)

K153670Genteel Lancing DeviceGenteel, LLC K172712gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerGri Medical & Electronic Technology Co., Ltd. K193009Promisemed Heel Blood LancetPromisemed Hangzhou Meditech Co., Ltd. K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd. K210745Heel Incision Safety LancetSteriLance Medical (Suzhou), Inc. K223243BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ LancetsBecton, Dickinson and Company

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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