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 |
| 28886354703073 | K222224 | 000 |
| 28886354703066 | K222224 | 000 |
Trademark Results [SurgiLance]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURGILANCE 78676623 3199761 Live/Registered |
MEDIPURPOSE PTE. LTD. 2005-07-22 |
 SURGILANCE 78147623 2800282 Dead/Cancelled |
MEDIPURPOSE PTE. LTD. 2002-07-25 |
 SURGILANCE 78147603 2800281 Dead/Cancelled |
MEDIPURPOSE PTE. LTD. 2002-07-25 |
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