SurgiLance® Safety Lancet

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

MediPurpose Pte. Ltd.

The following data is part of a premarket notification filed by Medipurpose Pte. Ltd. with the FDA for Surgilance® Safety Lancet.

Pre-market Notification Details

• Device ID: K222224
• 510k Number: K222224
• Device Name: SurgiLance® Safety Lancet
• Classification: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
• Applicant: MediPurpose Pte. Ltd. 10 Anson Road, No. 12-08 International Plaza Singapore, SG 079903
• Contact: Adeline Yi
• Correspondent: Julie Stephens; Regulatory Resources Group, Inc. 111 Laurel Ridge Drive Alpharetta, GA 30004
• Product Code: FMK
• CFR Regulation Number: 878.4850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-07-25
• Decision Date: 2022-09-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
28886354703080	K222224	000
58886354701032	K222224	000
18886354703083	K222224	000
18886354703076	K222224	000
18886354703069	K222224	000
18886354702857	K222224	000
18886354702642	K222224	000
58886354701919	K222224	000
58886354701902	K222224	000
58886354701896	K222224	000
18886354701867	K222224	000
58886354703098	K222224	000
58886354703050	K222224	000
58886354701049	K222224	000
58886354701056	K222224	000
58886354701063	K222224	000
28886354703073	K222224	000
28886354703066	K222224	000
58886354702244	K222224	000
58886354702237	K222224	000
58886354702220	K222224	000
58886354702213	K222224	000
58886354702206	K222224	000
58886354702190	K222224	000
58886354702183	K222224	000
58886354702145	K222224	000
58886354701087	K222224	000
58886354701070	K222224	000
58886354702848	K222224	000