Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Heel Incision Safety Lancet (SteriHeel 2)

K-Number: K244036 · 2025-02-26

ApplicantSteriLance Medical (Suzhou), Inc.
Decision Date2025-02-26
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Heel Incision Safety Lancet (SteriHeel 2) is a medical device manufactured by SteriLance Medical (Suzhou), Inc.. It received FDA 510(k) clearance on 2025-02-26 under approval number K244036. 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 Heel Incision Safety Lancet (SteriHeel 2)?

Heel Incision Safety Lancet (SteriHeel 2) is a medical device that received FDA 510(k) clearance on 2025-02-26. It is manufactured by SteriLance Medical (Suzhou), Inc.. The 510(k) number is K244036.

When was Heel Incision Safety Lancet (SteriHeel 2) approved by the FDA?

Heel Incision Safety Lancet (SteriHeel 2) received FDA 510(k) clearance on 2025-02-26, under approval number K244036.

What company makes Heel Incision Safety Lancet (SteriHeel 2)?

Heel Incision Safety Lancet (SteriHeel 2) is manufactured by SteriLance Medical (Suzhou), Inc..

What is the FDA product code for Heel Incision Safety Lancet (SteriHeel 2)?

The FDA product code for Heel Incision Safety Lancet (SteriHeel 2) is FMK.

Related Clinical Trials

NCT07222514 Feasibility and Safety of Single-Port Robotic-Assisted Deep Inferior Epigastric Pedicle Flap Harvest RECRUITING NCT04115605 A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence TERMINATED NCT06796504 The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study RECRUITING NCT05744934 Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study COMPLETED NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING NCT05941273 A Study of the SING IMT in an Israeli Cohort WITHDRAWN

Other Devices by SteriLance Medical (Suzhou), Inc.

K153706Insulin Pen Needle K210745Heel Incision Safety Lancet K221521Disposable Safety Lancet K221507Disposable Blood Lancet K221970Lancing device K233796Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)

View all 8 devices →

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.

↑