FDA 510(k)

gentleheel® Adult Incision Device

K-Number: K242664 · 2024-11-05

Decision Date2024-11-05

Product CodeFMK

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

gentleheel® Adult Incision Device is a medical device manufactured by Gri-Alleset, Inc.. It received FDA 510(k) clearance on 2024-11-05 under approval number K242664. 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® Adult Incision Device?

gentleheel® Adult Incision Device is a medical device that received FDA 510(k) clearance on 2024-11-05. It is manufactured by Gri-Alleset, Inc.. The 510(k) number is K242664.

When was gentleheel® Adult Incision Device approved by the FDA?

gentleheel® Adult Incision Device received FDA 510(k) clearance on 2024-11-05, under approval number K242664.

What company makes gentleheel® Adult Incision Device?

gentleheel® Adult Incision Device is manufactured by Gri-Alleset, Inc..

What is the FDA product code for gentleheel® Adult Incision Device?

The FDA product code for gentleheel® Adult Incision Device is FMK.

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Other Devices by Gri-Alleset, Inc.

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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.