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FDA 510(k)

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System

K-Number: K233185 · 2023-10-24

ApplicantC2dx, Inc.
Decision Date2023-10-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System is a medical device manufactured by C2dx, Inc.. It received FDA 510(k) clearance on 2023-10-24 under approval number K233185. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System?

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System is a medical device that received FDA 510(k) clearance on 2023-10-24. It is manufactured by C2dx, Inc.. The 510(k) number is K233185.

When was MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System approved by the FDA?

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System received FDA 510(k) clearance on 2023-10-24, under approval number K233185.

What company makes MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System?

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System is manufactured by C2dx, Inc..

What is the FDA product code for MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System?

The FDA product code for MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System is GEI.

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Official Source

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

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