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FDA 510(k)

Smart Scope® CX

K-Number: K233043 · 2024-06-14

ApplicantPeriwinkle Technologies Pvt., Ltd.
Decision Date2024-06-14
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Smart Scope® CX is a medical device manufactured by Periwinkle Technologies Pvt., Ltd.. It received FDA 510(k) clearance on 2024-06-14 under approval number K233043. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smart Scope® CX?

Smart Scope® CX is a medical device that received FDA 510(k) clearance on 2024-06-14. It is manufactured by Periwinkle Technologies Pvt., Ltd.. The 510(k) number is K233043.

When was Smart Scope® CX approved by the FDA?

Smart Scope® CX received FDA 510(k) clearance on 2024-06-14, under approval number K233043.

What company makes Smart Scope® CX?

Smart Scope® CX is manufactured by Periwinkle Technologies Pvt., Ltd..

What is the FDA product code for Smart Scope® CX?

The FDA product code for Smart Scope® CX is HEX.

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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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