MallyaG Injection Pen Adapter (MallyaG)— 510(k) K251500

Name: FDA 510(k) clearance K251500
Creator: U.S. Food and Drug Administration
Published: 2025-06-09

Substantially Equivalent

Biocorp Production

FDA 510(k) clearance K251500 for MallyaG Injection Pen Adapter (MallyaG), Substantially Equivalent on 2025-06-09. Applicant: Biocorp Production. Device class: 2.

Clearance details

Applicant: Biocorp Production
Product code: Code QOG
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2025-05-15
Decision date: 2025-06-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Issoire, FR

Download summary PDF View on FDA.gov ↗

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K231820 — SoloSmart Injection Pen Adapter (SoloSmart®)2024-01-12
K222689 — Mallya Injection Pen Adapter (Mallya® for Solostar®)2022-12-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.