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Genteel Lancing Device

by Genteel, LLC

510(k) K153670

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK153670 Date12 May 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FMK
Device Class
Class II
Regulation
21 CFR Part 878.4850
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Genteel Lancing Device is a medical device designed for blood glucose testing. It uses vacuum technology and a cushioned tip to perform lancing with a shallow prick, aiming to minimize pain during blood sampling.

This device is supplied as a single-use or reusable product, depending on the components used. It includes the lancing device, 6 contact tips, 10 butterfly touch lancets, and instructions. The device has received FDA 510(k) clearance with the product code FMK and was determined to be substantially equivalent.

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