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FDA 510(k)

MallyaG Injection Pen Adapter (MallyaG)

K-Number: K251500 · 2025-06-09

ApplicantBiocorp Production
Decision Date2025-06-09
Product CodeQOG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MallyaG Injection Pen Adapter (MallyaG) is the device name listed in this FDA 510(k) record. The listed applicant is Biocorp Production. It received FDA 510(k) clearance on 2025-06-09 under 510(k) number K251500. The device is classified under product code QOG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MallyaG Injection Pen Adapter (MallyaG)?

MallyaG Injection Pen Adapter (MallyaG) is a medical device that received FDA 510(k) clearance on 2025-06-09. The listed applicant is Biocorp Production. The 510(k) number is K251500.

When did MallyaG Injection Pen Adapter (MallyaG) receive FDA 510(k) clearance?

MallyaG Injection Pen Adapter (MallyaG) received FDA 510(k) clearance on 2025-06-09, under 510(k) number K251500.

Who is the listed applicant for MallyaG Injection Pen Adapter (MallyaG)?

The FDA 510(k) record lists Biocorp Production as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MallyaG Injection Pen Adapter (MallyaG)?

The FDA product code for MallyaG Injection Pen Adapter (MallyaG) is QOG.

Other records listing Biocorp Production as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250555MallyaD injection pen adapter (MallyaD)K231820SoloSmart Injection Pen Adapter (SoloSmart®)K222689Mallya Injection Pen Adapter (Mallya® for Solostar®)

Related Devices (Code: QOG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243901SmartPilot YpsoMate NS-A2.25Ypsomed AGK250555MallyaD injection pen adapter (MallyaD)Biocorp ProductionK241803INSULCLOCK® v2.0 PROInsulcloud S.L.K231820SoloSmart Injection Pen Adapter (SoloSmart®)Biocorp ProductionK222689Mallya Injection Pen Adapter (Mallya® for Solostar®)Biocorp ProductionK212217Tempo Smart ButtonEli Lilly and Company

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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