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FDA 510(k)

Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle

K-Number: K203792 · 2023-01-20

ApplicantPikdare Spa
Decision Date2023-01-20
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle is a medical device manufactured by Pikdare Spa. It received FDA 510(k) clearance on 2023-01-20 under approval number K203792. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle?

Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle is a medical device that received FDA 510(k) clearance on 2023-01-20. It is manufactured by Pikdare Spa. The 510(k) number is K203792.

When was Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle approved by the FDA?

Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle received FDA 510(k) clearance on 2023-01-20, under approval number K203792.

What company makes Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle?

Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle is manufactured by Pikdare Spa.

What is the FDA product code for Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle?

The FDA product code for Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle is FMI.

Related Clinical Trials

NCT06253494 Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer RECRUITING

Other Devices by Pikdare Spa

K223353DropSafeTM SicuraTM

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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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