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510(k) K233796

Device
Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)
Applicant
SteriLance Medical (Suzhou), Inc.
510(k) number
K233796
Product code
FMK
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-16
Date received
2023-11-29
Regulation
878.4850
Classification name
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Susan Sun
Address
#168 Putuoshan Rd. New District Suzhou CN 215153 215153

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FMK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261045Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd.2026-05-01
K260191Safety lancet (XXXVII)Tianjin Huahong Technology Co., Ltd.2026-03-31
K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd.2026-02-20
K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd.2026-02-12
K251694safety lancetTianjin Huahong Technology Co., Ltd.2025-06-26
K244036Heel Incision Safety Lancet (SteriHeel 2)SteriLance Medical (Suzhou), Inc.2025-02-26
K243533Sterilized Eol Auto Lancet; Sterilized Eol Lancet PlusHlb Co., Ltd. Healthcare2025-01-13
K242680LetsGetChecked ImpressPrivapath Diagnostics Ltd (Dba Letsgetchecked)2025-01-13
K242664gentleheel® Adult Incision DeviceGri-Alleset, Inc.2024-11-05
K242627Safety LancetNingbo Medsun Medical Co., Ltd.2024-10-30
K242316Safety LancetNingbo Medsun Medical Co., Ltd.2024-08-28
K241848MedtFine Safety LancetNingbo Caremed Medical Products Co., Ltd.2024-08-20
K241750Medifun Safety Lancet ( MSL1 series)Medifun Corporation2024-08-15
K241627Safety Lancet (XXXV)Tianjin Huahong Technology Co., Ltd.2024-06-20
K240806Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)Tianjin Huahong Technology Co., Ltd.2024-05-21