← Back to catalogue

SURGILANCE SAFETY LANCETS - Slb200

FDA 510(k)

Class II (US FDA 510(k))

510(k) K101145

by Medipurpose Pte. Ltd.

Identifiers

510(k) Number
K101145 FDA 510(k)
FDA Product Code
FMK FDA 510(k)
Models / Variants
Sln100 FDA 510(k)
Sln200 FDA 510(k)
Sln240 FDA 510(k)
Sln300 FDA 510(k)
Slb200 FDA 510(k)
Slb250 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4850 FDA 510(k)
Regulation Number
878.4850 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

SURGILANCE SAFETY LANCETS - Slb200 by Medipurpose Pte. Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 6 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medipurpose Pte. Ltd.
FDA Applicant
Medipurpose Pte. , Ltd.

Sources (1)

  • FDA 510(k) K101145 24 fields · synced Jun 18, 2026