Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IVD CAPSULE PSP; abioSCOPE

K-Number: K240041 · 2024-09-25

ApplicantAbionic SA
Decision Date2024-09-25
Product CodeSCX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IVD CAPSULE PSP; abioSCOPE is a medical device manufactured by Abionic SA. It received FDA 510(k) clearance on 2024-09-25 under approval number K240041. The device is classified under product code SCX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVD CAPSULE PSP; abioSCOPE?

IVD CAPSULE PSP; abioSCOPE is a medical device that received FDA 510(k) clearance on 2024-09-25. It is manufactured by Abionic SA. The 510(k) number is K240041.

When was IVD CAPSULE PSP; abioSCOPE approved by the FDA?

IVD CAPSULE PSP; abioSCOPE received FDA 510(k) clearance on 2024-09-25, under approval number K240041.

What company makes IVD CAPSULE PSP; abioSCOPE?

IVD CAPSULE PSP; abioSCOPE is manufactured by Abionic SA.

What is the FDA product code for IVD CAPSULE PSP; abioSCOPE?

The FDA product code for IVD CAPSULE PSP; abioSCOPE is SCX.

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.

↑