510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242664Substantially Equivalent

gentleheel® Adult Incision Device

GRI-Alleset, Inc., Flowery Branch GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K242664 is the FDA 510(k) clearance record for gentleheel® Adult Incision Device, a class II device, cleared for Gri-Alleset, Inc. on under FDA product code FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature). FDA's definition for product code FMK reads: "A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop...". FDA records list 4 510(k) clearances for Gri-Alleset, Inc., from to . As of , FDA records show no recalls naming K242664.

Clearance record

Decision date
Received
(62 days to decision)
Product code
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Regulation
21 CFR 878.4850
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Gri-Alleset, Inc. 4142 Industry Way, Flowery Branch GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FMK

Trailing 12 months
5 clearances under product code FMK in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FMK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260